339 Medical Affairs jobs in the United Kingdom

We are seeking a highly experienced and strategically minded Freelance Medical Affairs Director to lead and support medical affairs activities for our UK operations. In this role you will need to play a key leadership role in shaping scientific strategy, managing external relationships, and ensuring medical governance for products across their lifecycle.

Key Responsibilities

• Lead UK Medical Affairs strategy and execution across designated therapeutic areas
• Oversee development and delivery of medical plans aligned with corporate and product strategy
• Lead external engagement with key opinion leaders (KOLs), healthcare professionals (HCPs), and advisory boards
• Ensure compliance with ABPI Code of Practice and relevant regulatory frameworks
• Oversee review and approval of promotional and non-promotional materials (via copy approval processes)
• Provide medical input for HTA submissions, pricing and reimbursement discussions
• Support clinical development and real-world evidence (RWE) activities as needed
• Manage freelance MSLs, medical writers, or other contract staff if applicable

Qualifications & Experience

• Medical degree (MD, MBBS) or PhD in a relevant life science discipline
• Minimum 8–10 years' experience in Medical Affairs roles, ideally within the UK pharma or biotech sector
• Strong knowledge of UK pharmaceutical regulations and ABPI Code
• Demonstrated ability to lead medical strategy and stakeholder engagement
• Experience working in freelance, consulting, or contract medical roles desirable
• Wide experience across multiple therapeutic areas.

Skills & Competencies

• Strategic thinker with hands-on execution ability
• Excellent communication, influencing, and stakeholder management skills
• Able to operate autonomously in a fast-paced, matrixed environment
• Comfortable managing both high-level strategy and operational details
• ABPI Final Signatory status (preferred or required, depending on need)

We are excited to introduce one of the first dedicated international medical operations roles at Regeneron. As Associate Director, Field Excellence, you will help standardize and operationalize Medical Affairs across international markets, supporting a consistent and aligned approach to how we work. This high-visibility position will play a central role in embedding our new Medical Affairs operating model into daily field activities-shifting from activity-based to impact-based metrics, aligning systems, and building consistent operational standards across countries. Working closely with global Medical Affairs and international team members, you'll help craft how field medical operates for years to come.
**A Typical Day:**
+ Partnering with country teams to understand current practices and align them to a unified global operating model.
+ Acting as the business lead for international on field medical tools and systems, including CRM, metrics, and reporting platforms.
+ Driving a shift from activity-based to impact-based measurement of medical outcomes.
+ Collaborating with cross-functional partners to ensure operational alignment.
+ Coordinating the execution of Medical Impact Plans across international regions.
+ Supporting consistent role definitions and clear executional responsibilities across markets.
+ Facilitating adoption of standardized processes for medical insights capture and utilization.
**This Role May Be For You:**
+ You are motivated by building operational frameworks from the ground up in a global setting.
+ You can lead without authority and bring team members along during periods of change.
+ You excel at standardizing processes while respecting local market needs.
+ You are comfortable navigating complex, cross-country operational challenges.
+ You thrive in collaboration with diverse functions such as compliance, commercial training, and medical operations.
+ You adapt quickly, work well with ambiguity, and maintain a solutions-focused attitude.
**To Be Considered:**
You hold an advanced degree in life sciences or a related field (MSc, PhD, PharmD, or MD preferred) and bring 10+ years of experience in the biopharmaceutical industry, with proven success in medical affairs operations, field medical alignment, or adjacent functions. Your background includes project or operations leadership, system implementation, and cross-country alignment-ideally with exposure to field medical environments (e.g., MSL, field operations lead, or affiliate leadership). International experience is essential; oncology experience is an advantage but not required. This is a remote role based in Europe or the UK, attached to any Regeneron office (excluding Switzerland), with occasional travel and regular cross-time-zone collaboration.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Our client, a leading pharmaceutical company, is seeking an experienced and highly motivated Senior Medical Affairs Manager to join their team in **Derby, Derbyshire, UK**. This critical role will focus on developing and executing medical strategies that support the company's innovative product portfolio. You will be responsible for engaging with key opinion leaders (KOLs), scientific societies, and patient advocacy groups to foster collaboration and disseminate scientific information. The successful candidate will possess a deep understanding of the pharmaceutical industry, regulatory affairs, and clinical research. Key responsibilities include developing and managing medical affairs plans, overseeing the creation of scientific materials, and ensuring compliance with all relevant regulations and ethical guidelines. You will also play a vital role in training and supporting the medical science liaison (MSL) team. This position requires strong analytical skills, excellent written and verbal communication abilities, and a proactive approach to problem-solving. The ideal candidate will have a scientific or medical background, with a minimum of 7 years of experience in medical affairs within the pharmaceutical sector. A strong network of KOLs is highly desirable. You will be a key contributor to the company's mission of improving patient outcomes through cutting-edge therapies. Responsibilities:

• Develop and implement strategic medical affairs plans.
• Identify and engage with key opinion leaders (KOLs).
• Oversee the creation and review of scientific publications and educational materials.
• Provide scientific and medical support to internal teams.
• Manage and mentor the MSL team.
• Ensure compliance with all regulatory and ethical standards.
• Contribute to clinical trial activities and data interpretation.
• Represent the company at scientific conferences and meetings.

Qualifications:

• Advanced degree (MD, PhD, PharmD, MSc) in a relevant scientific or medical field.
• Minimum of 7 years of progressive experience in medical affairs in the pharmaceutical industry.
• Proven experience in therapeutic area relevant to the company's pipeline.
• Strong understanding of clinical development, regulatory affairs, and pharmacovigilance.
• Excellent communication, presentation, and interpersonal skills.
• Demonstrated leadership and team management abilities.
• Ability to travel as required.

This is a significant opportunity to influence medical strategy and drive scientific exchange in **Derby, Derbyshire, UK**.

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
+ Reporting to the UK Medical Director, leading a team of 26.
+ Based in the offices in Maidenhead (3 days a week) with 2 days flexible working.
+ Highly competitive salary, Car allowance, LTi's, Bonus and comprehensive benefits package.
Overview:
To effectively structure, build and lead the UK Oncology Medical Affairs Department, providing guidance and support to the team in defining critical strategies and executing innovative medical activities that support the therapy area. To inspire and develop a high performing Oncology Medical Affairs team.
To develop strong partnerships with external and internal stakeholders i.e. Healthcare Professionals, members of the Brand Team, Medical Director, Regional and Global Medical Affairs colleagues as well as other internal functions e.g. Site Management and Monitoring, Legal, Finance.
To ensure that the medical affairs role is fully integrated to support the strategy and execution of affiliate business, while being functionally independent.
Key responsibilities include:
+ Build and provide leadership to the UK Oncology Medical Affairs team
+ Lead the UK Oncology Medical Affairs department in defining critical strategies and executing medical activities that support the therapy area.
+ Ensure proactive scientific and clinical input by members of the Medical Division and the Oncology Medical Affairs Department into the Brand teams and key brand initiatives.
+ Assist and advise Brand team members on promotional activities, and ensure compliance with the ABPI Prescription Medicines Code of Practice
+ Respond to Inter-company Code of Practice complaints and liaise with the PMCPA
+ Develop and maintain in-depth knowledge of the company's products, the therapeutic area and the structure and workings of the NHS
+ Establish and develop strong relationships with key external customers including External Experts, Public Bodies e.g. Department of Health, MHRA and key external influencers e.g. NHSE.
+ Ensure appropriate support by the Medical Affairs Team for relevant personnel on disease/product knowledge
+ Ensure appropriate support to the Site Management and Monitoring team to achieve UK study targets for global clinical trials with UK sites.
+ Ensure clinical support is provided to HTA Department including input into HE strategy and Health Technology Assessment submissions. Also assist with interactions with Market Access/HTA Bodies where appropriate.
+ Ensure clinical support/guidance and training is provided to all other functions within the Medical Division and UK affiliate, as required.
+ Respond to requests for individual named patient supplies as required
+ Ensure appropriate HMT and CME training requirements are met for all physicians within the Medical Affairs Department, for example, support revalidation for doctors with Faculty of Pharmaceutical Medicine.
+ Lead the brand-aligned medical team and ensure its compliance to corporate requirements and processes on medical activities
+ Drive Medical Strategy and align with Global strategies for the Brand within the Brand Team and integrate it into the Brand Plan
+ Oversee Medical activities within the Brand Team, according to local resources and regulations
Qualifications
+ Medically qualified with clinical experience post-registration and GMC registered or PhD scientist or pharmacist background.
+ Experience of leading and developing a team in a complex matrix organisation within the pharmaceutical industry.
+ Experience of working in Oncology would be an advantage.
+ Ability to think and plan strategically and to adopt an open-minded approach to common challenges.
+ Ability to deal with conflicting interests within a multi-functional team and the leadership skills to bring these interests together towards a common goal.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Director, Global Medical Affairs Neuropsychiatry
Date: Jul 29, 2025
Location:
Harlow, United Kingdom, CM20 2FB
Company: Teva Pharmaceuticals
Job Id: 62688
**Who We Are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The Opportunity**
This is an exciting opportunity for an experienced medical affairs leader to shape the future of psychiatry at a global level. As Director of Global Medical Affairs, Neuropsychiatry, you will play a pivotal role in driving the medical and scientific strategy for psychiatry, working in close partnership with the Therapeutic Area (TA) lead and the wider GMANeuropsychiatryteam. You'll lead the development and execution of strategic plans to support the successful launch and lifecycle management of key assets, while building strong collaborations with external experts, scientific bodies, and patient representatives. This role offers the chance to provide influential medical guidance across early and late-stage development, as well as commercialised products, ensuring robust scientific leadership across clinical research, medical launch preparation, and health economics strategy.
Location:
Ideally, the successful candidate would be based within a commutable distance from either our Harlow or Ridings Points sites. However, we'd be open to receiving applications from those based anywhere across The UK, subject to your openness to national/international travel c.10%-20% of your working hours
**How You'll Spend Your Day**
**Key Responsibilities**
+ Medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines within psychiatry
+ Responsible for the development and execution of the Global Medical Affairs plan for the relevant asset(s). These will include, amongst others, responsibilities such as Phase IV trial activities (such as protocol development, study execution, medical governance and interpretation of results); development of Key Opinion Leader (External Experts) strategy and plan; scientific congress activities (such as medical symposium, presentation of abstracts and or posters); input to publication strategy and review of Investigator Sponsored Studies/Collaborative Research/GHEVO studies.
+ In partnership with the TA lead and team provides coordination and execution of overall medical strategy for Teva's assets in psychiatry in close collaboration with Regional Medical Affairs teams, from initiation of regional pre-launch activities to several years post-launch (as relevant)
+ Again, alongside the TA lead contributes to and implements the world-wide medical psychiatry strategy
+ Interfaces effectively with other Global Medical Affairs functions such as Scientific Communications and Global Health Economics, Value and Outcomes, and other departments, including Commercial, Clinical Development, Regulatory Affairs and Pharmacovigilance
+ Provides counsel to clinical development with input on early and late-stage development plans, target product profile, and lifecycle management
+ Collaborates with Global Scientific Communications in support of knowledge generation for the psychiatry franchise, including strategy development and review of manuscripts, abstracts and posters as part of the publication team
+ Develops and maintains professional relationships with external experts and professional associations including therapeutic guideline development groups. Responsible for the External Expert interface for the respective psychiatry medicines
**Your Experience And Qualifications**
**Do you have.**
+ Preferably, a life sciences degree / MD / MPharm, PhD and at least five years pharmaceutical industry experience.
+ Experience in designing and executing PIV studies- this would be beneficial
+ Pharmaceutical industry experience in global medical affairs, ideally in psychiatry or neuroscience.
+ Experience in successfully developing strategy and executing medical plans, and in building professional external expert networks.
+ A broad knowledge of drug development, clinical trial design, regulatory requirements, business development and life cycle management.
**Are you.**
+ Able to build strong work relationships with all stakeholders involved
+ Able to work in a changing and flexible environment
+ Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R&D, health outcomes, regulatory, pharmacovigilance and compliance.
+ Bringing a leadership skillset and comfort working within a matrix set-up
+ Able to translate complex scientific content into what this means in medical practice for the HCP and patient
+ Driven by the pride in your work
+ A strategic thinker
If so, we'd value hearing from you.
**Enjoy A More Rewarding Choice**
We support our people through every stage of their journey with us. Our flexible reward platform puts you in control, empowering you to tailor your benefits to fit your lifestyle, priorities, and what matters most to you. With 25 days of annual leave that grows with your service, the flexibility to purchase additional days, and two dedicated volunteering days each year, your time off is truly yours to enjoy, recharge, and give back. We prioritise your health with private medical insurance, life assurance, critical illness cover, and income protection.
Whether you're growing your family or pursuing new adventures, our enhanced maternity and paternity leave, sabbaticals, and hybrid working policies are here to support you through life's most meaningful moments. Financial wellbeing matters too, which is why we offer an enhanced pension scheme, access to a discount store, and free financial coaching through Bippit.
To help you grow with confidence, we offer a structured training and development programme tailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.
**Already Working @TEVA?**
#TJ If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Application deadline for internal candidates will close on Tuesday 12th August 2025
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary**
The Senior Director, Managed Access Programs (MAPs) will be responsible for partnering to develop the strategy and lead the global implementation and management of Managed Access Programs across multiple disease areas. This role supports the company's health equity ambition, ensuring that patients with unmet needs receive access to our innovative medicines in a compliant and ethical manner. The MAPs Lead will provide strategic input, oversight, and coordination to ensure a streamlined and efficient approach to managed access and ensure equity, sustainability, scalability, and appropriate data capture across their respective disease areas. She/He will work closely with cross-functional teams ensuring the implementation of appropriate policies, processes, and systems that support the centralized managed access strategy. Additionally, this role will be accountable for ensuring compliance with country-specific regulations and effective data capture.
This role reports to the Executive Director, Managed Access.
**Key Responsibilities**
Strategic Planning :
+ Collaborate with key partners (WW TA, DD, legal, compliance, RCO, Country medical teams) to define and develop the managed access strategy for assets across multiple diseases TAs.
+ Ensure the managed access strategy has input from all required partners and goes through the appropriate review and governance processes.
MAP Oversight :
+ Partner with GDO/RCO to ensure seamless operationalization of managed access programs for their respective disease areas, ensuring appropriate country rules are followed.
+ Implement standardized policies, procedures, and best practices across the portfolio of managed access programs
+ Establish and track key performance indicators (KPIs) to measure the success of the managed access programs and leverage data and analytics to optimize MAPs and accelerate Impact.
Cross-Functional Collaboration : Serve as the primary point of contact for internal (Medical Affairs, Development, Commercial, Regulatory Affairs, Legal, and Compliance) and external stakeholders to ensure seamless program execution and compliance with global, regional, and local regulations and guidelines.
Data Capture and Evidence Generation :
+ Optimize the capture and utilization of data and evidence from MAPs that appropriately supports the value of BMS' assets and ensure that data collection processes comply with country-specific regulations and privacy laws.
Training and Support : Provide training and support to internal teams on MAP processes and best practices.
Innovation : Foster an innovative culture and lead initiatives to increase innovative approaches to MAPs.
**Qualifications & Experience**
+ Educational Background: Degree in a relevant field (e.g., Life Sciences, Patient Access, Pharmacy, Public Health) required.
+ Industry Experience: Minimum of 7+ years of experience in the pharmaceutical or biotechnology industry, with at least 3 years in a role related to managed access. Proven track record of successfully managing MAPs across a disease area.
+ Regulatory / Compliance Knowledge: In-depth knowledge of global and local regulations and guidelines related to Managed Access Programs.
+ Communication Skills: Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels.
+ Strategic Thinking: Strategic thinker with strong analytical and problem-solving abilities.
+ Adaptability: Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
The starting compensation for this job is a range from $229,380 - $278,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers ( site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**#LI-HYBRID**
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1594020
**Updated:** 2025-08-26 04:45:52.196 UTC
**Location:** Madison-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Regulatory Affairs Manager / Remote / 24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications , particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal , manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

• Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2 .
• Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
• Develop and execute regulatory submission strategies , including review of CMC and IMPD data.
• Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
• Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
• Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
• Review and manage project budgets, ensuring scope alignment and revenue recognition.
• Support global regulatory initiatives and contribute to SOP development and review.
• Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

• Minimum 8 years of relevant regulatory experience in life sciences.
• Proven expertise in EUCTR , CTIS , and clinical trial applications .
• Strong technical writing skills, particularly in compiling IMPD and CMC data.
• Strategic mindset with experience in regulatory planning and client-facing communication.
• Ability to manage multiple projects, with assignments varying based on project size and scope.
• Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

• Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa .
• Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
• Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.

__PRESENT__PRESENT

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group of companies includes Gi Group Holdings Recruitment Ltd, Gi Recruitment Ltd, Draefern Ltd, Excel Resourcing (Recruitment Consultants) Ltd, Gi Recruitment Ltd, INTOO (UK) Ltd, Marks Sattin (UK) Ltd, TACK TMI UK Ltd, TACK International Ltd, Grafton Professional Staffing Ltd, Encore Personnel Services Ltd, Gi Group Staffing Solutions Ltd and Gi Group Ireland Ltd. Gi Group Staffing Solutions Ltd are acting as an Employment Business in relation to this role.

We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website.

Regulatory Affairs Officer
Location: Chester
Salary: £38,000 – £42,000 per annum
Hours: Monday – Friday, Standard Day Shifts
Benefits: Generous Annual Leave, Enhanced Private Health Insurance, Top Tier Pension Contributions 

Are you a detail-driven professional passionate about pharmaceutical compliance? Trek Recruitment is delighted to recruit for our client, a forward-thinking pharmaceutical leader based near Chester. We’re seeking an experienced Regulatory Affairs Officer to join their dynamic team, offering a fantastic opportunity to grow within an award-winning organisation and to take the rains and bring parts of the regulatory affairs process in-house. 

THE ROLE
As a Regulatory Affairs Officer you will be -

• Preparing and managing regulatory documentation for a diverse product portfolio.
• Organising and maintaining compliant regulatory records as per industry standards.
• Tracking and reporting regulatory project progress to stakeholders.
• Keeping abreast of regulatory changes and communicating updates to internal teams.
• Monitoring industry trends to ensure ongoing compliance with pharmaceutical regulations.
• Supporting client communications related to regulatory processes and updates.

Who We’re Looking For Our client seeks a motivated individual with a solid regulatory background , someone to make the job their own and help the department grow.

YOU

To thrive in this role, you will need:

• A Bachelor’s degree in a scientific, healthcare, or related field.
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Exceptional organisational skills and meticulous attention to detail.
• Strong written and verbal communication skills.
• Adaptability to evolving regulatory requirements.
• A collaborative spirit, excelling in team-oriented settings.
• Proficiency in standard office software (e.g., Microsoft Word, Excel, Outlook).
• A drive for professional development in regulatory affairs.
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

Desirable Qualifications

• Experience with regulatory submissions for new products or post-market changes.

Keywords: Regulatory Affairs Officer, Pharmaceutical Jobs, Deeside Careers, Regulatory Compliance, GMP, GCP, Pharmaceutical Industry, Trek Recruitment, Top Workplace 2024, Healthcare Jobs.

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!