152 Consumer Officer jobs in the United Kingdom

Job Title: Regulatory Affairs Consultant

Location: Maidenhead

Contract: 12 months / hybrid 3 days onsite

Hours: 37.5 per week

Rates: 50-60p/h

Job Description

SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be Supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Duties and Responsibilities

Overall responsibilities

With supervision and guidance from Line Manager;

• Acts as the primary Regulatory contact for identified portfolio.
• Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
• Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
• Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.

• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
• Regulatory intelligence and external landscape monitoring - provides regulatory impact assessment and establishes best practice

Main Accountabilities

• Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.

• Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements

• Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures

• Keeps up to date with all appropriate Regulatory issues and operate as a 'problem-solver', to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Director, Regulatory Affairs as necessary.

• Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross-functional working.

• Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.

Experience and Qualifications

• Life Sciences Degree or equivalent experience
• Varied experience within UK or EU Regulatory Affairs, including clinical trials, paediatric investigation plans, license lifecycle management
• Excellent communication skills, both verbal and written
• Effective influencing, tactical and presentation skills
• Effective project management experience
• Consultative and collaborative interpersonal style
• Excellent English language skills
• The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

Job Title: Regulatory Affairs Manager

Location: Maidenhead

Contract: 12 Months / Hybrid 3 days per week onsite

Hours: 37.5 hours per week

Rates: 80-90p/h

Job Description

SRG are seeking a regulatory affairs manager for a leading pharmaceutical company based in Maidenhead. For this role you will be working in collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.

Duties and Responsibilities

In consultation with line manager and/or Area Product Lead;

• Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives.
  • Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal.
  • Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation.
  • Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives
• Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation.
• Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
• GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT
• Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
• Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required.

• Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools
• Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.

People

• Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities.

• Potential to mentor less experienced Area regulatory colleagues as required

Processes

• Follows Global Regulatory policies and procedures.
• Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs.
• Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
• Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects.

Experience and Qualifications

• Graduate in Life Sciences in a relevant area.
• Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area.
• Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures, EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans preferred.
• Experience working effectively across cultures and in complex matrixed environment.
• Excellent organizational skills and solution driven leadership style

Essential Skills and Abilities

• Ability to prioritise and manage workload including managing multiple projects.
• Ability to work effectively and collaboratively across the organisation.
• Experienced in working effectively across cultures and in complex matrix environment.
• Good interpersonal and negotiation skills and the ability to influence others.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

Are you passionate about regulatory affairs and eager to help life-changing medical products reach the market? Our client is looking for a Regulatory Affairs Officer to support their team in guiding pharmaceutical, medical device, cosmetics and life sciences companies through complex regulatory landscapes.

Whilst part of a team, you will work independently. Aside from regulatory submissions, you will engage with clients providing regular updates and advice on projects. This is a great opportunity to further develop your regulatory knowledge and consulting skills.

Key Responsibilities

• Assist in preparing and submitting regulatory documents for UK, EU and US markets mainly on medical devices
• Support clinical trial processes, registries and Post-Market Clinical Follow-up studies
• Research evolving regulatory frameworks to keep strategies cutting-edge
• Provide updates, presentations and regular communication with clients across multiple time lines
• Work alongside senior consultants to develop tailored compliance solutions

Requirements

• A degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs or a related field
• An understanding of clinical trials, registries, and PMCF requirements
• Experience liaising with regulatory authorities and clients and presenting detailed reports to them
• Familiarity with global regulatory bodies and frameworks
• Strong IT skills and attention to detail
• Excellent communication and problem-solving abilities

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

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!

Overall Job Purpose:

The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.

Responsibilities:

• Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
• Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
• Is responsible for text verification of the product information documents.
• Is responsible for proof reading of art work of packaging materials.
• Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
• Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
• Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
• Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
• Maintains RA archives (electronically).
• Keeps the Regulatory Information correct and accessible for other stakeholders.
• Being able to work with the required IT standards, like eCTD, XEVMPD
• Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
• Determines and writes standard operating procedures.

Qualifications:

• Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
• 2-5 years of experience in pharma
• Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
• Some understanding of the drug development process
• Able to comply with company standard operating procedures
• Good verbal and written communication skills in English
• Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
• Excellent attention to detail
• Good time management skills
• Good organization and project management skills
• Good interpersonal and team working skills
• Presentation skills and experience of delivering training

Overall Job Purpose:

The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.

Responsibilities:

• Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
• Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
• Is responsible for text verification of the product information documents.
• Is responsible for proof reading of art work of packaging materials.
• Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
• Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
• Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
• Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
• Maintains RA archives (electronically).
• Keeps the Regulatory Information correct and accessible for other stakeholders.
• Being able to work with the required IT standards, like eCTD, XEVMPD
• Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
• Determines and writes standard operating procedures.

Qualifications:

• Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
• 2-5 years of experience in pharma
• Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
• Some understanding of the drug development process
• Able to comply with company standard operating procedures
• Good verbal and written communication skills in English
• Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
• Excellent attention to detail
• Good time management skills
• Good organization and project management skills
• Good interpersonal and team working skills
• Presentation skills and experience of delivering training

Job Title: Regulatory Affairs Team Lead (UK/EU)

Job Type: Full-time, Permanent

Location: High Wycombe, Buckinghamshire, UK (Hybrid)

Remuneration: Up to £70,000 + 7.5% Bonus

An opportunity working for a growing speciality pharmaceutical business that focuses on CNS products and hospital injectables as a Regulatory Affairs Team Lead/Manager. The role reports to the Director of Regulatory Affairs.

This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. Within this role, you will manage a team of 3 officers. P

This role plays a pivotal part in driving regulatory support for EU operations, contributing significantly to achieving company financial targets and fostering growth. This position holds a critical responsibility in harmonising regulatory efforts for EU products of the UK portfolio, particularly post-Brexit, where the business's Marketing Authorisation Holder (MAH), while regulatory oversight remains under the UK portfolio team.

Additionally, this role actively supports in-licensing and acquisitions across the UK and EU regions by collaborating closely with the business development team. Furthermore, it provides essential support for new product development initiatives and geographical expansion efforts in both the UK and EU regions by maintaining a seamless alignment with commercial strategies.

Another crucial aspect of the role involves the meticulous maintenance of a diverse product portfolio of In-house manufacturing and Contract Manufacturing Organisations for both the UK and EU markets, ensuring ongoing compliance with regulatory requirements and overseeing product lifecycle management activities.

Day-day responsibilities

• Portfolio Management : Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to relevant regulations and standards.
• Gap Analysis : Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies.
• New MA Applications : Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures.
• Geographical Expansion : Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.
• RA Support for New Product Development : Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset.
• In-licensing Support : Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio.
• MA Compliance Maintenance : Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team.
• Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations.
• Change Control Management : Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred.
• Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork.

Skills/Experience

• Experience in the pharmaceutical industry, minimum 8 years.
• A science degree.
• Working in a global matrix organisation and collaborating at all levels including external authorities and partners.
• Mutual Recognition and Decentralised Procedures.
• Philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function.
• Commercial sense, combined with an absolute commitment to high regulatory standards.
• Planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.

Benefits:

• Competitive salary (up to 75k)
• 25 days annual leave, rising to 30 with length of service plus bank holidays (prorated)
• Holiday Buy/Sell – an opportunity to buy or sell up to an additional 5 days of holiday
• 7.5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
• Bravo Benefits Platform – offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more
• Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
• Private Healthcare with an additional Medicash health cash plan

Working hours information

• Monday - Friday 37.5hrs per week, hybrid role.

This role does not offer sponsorship; you MUST be based in the UK and hold the FULL right to work. You MUST be able to get to the site 3x per week.

For more information, please reach out to

G&L Scientific is a leading consultancy specializing in Regulatory Affairs and Quality Assurance. Our mission is to provide expert guidance that empowers our clients to navigate complex regulatory environments effectively.

We are seeking a dedicated Regulatory Affairs Executive to join our team in Belfast. In this role, you will play a crucial part in ensuring compliance with regulatory standards, contributing significantly to our mission of delivering high-quality consultancy services. We are looking for someone who is

enthusiastic and willing to develop the skills and knowledge required of a Regulatory Affairs professional in areas such as the drug development process, regulatory affairs, submissions management, publishing and/or other regulatory operations activity and requires a quality approach to documentation and an eye for detail.

Responsibilities

• Keeping up to date with national and international regulatory legislation, guidelines, and customer practices
• Sharing of knowledge such as supporting the generation of training materials and regulatory intelligence
• Researching and authoring thought leadership content, to help build knowledge and understanding in a regulatory discipline.
• Support on high output regulatory project(s), which may involve preparation of high quality CMC regulatory documents using varied information sources and Regulatory Information Management (RIM) ensuring compliance in customers data.(
• Liaising closely with other stakeholders to ensure accuracy and completion of tasks to strict timelines.
• Working to agreed deadlines and maintaining records to reflect project status
• Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice

Required Skills

• Science related degree e.g Biological Sciences, Biomedical Science.(RO5)
• Desirable: Previous experience in a Regulatory Affairs role.(RO6)
• Strong written and oral communication and networking skills
• Demonstrate ability to focus and work with attention to detail
• Demonstrate ability to retain critical information
• Demonstrate team working and effective time management skills
• Be a dynamic and highly motivated individual
• Establish strong relationships and liaise effectively with all applicable stakeholders.
• Be proficient in the use of IT packages such as Word and excel.
• Demonstrate problem solving skills

If you are passionate about regulatory affairs and want to make a difference in the industry, we invite you to apply and join our dynamic team!