1,719 Pharmaceuticals jobs in the United Kingdom

Regulatory Medical Writer - Pharma Consultancy

Are you an experienced Regulatory Medical Writer looking to join a growing consultancy that partners with leading pharmaceutical and medical device companies worldwide? This is an exciting opportunity to play a key role in supporting Marketing Authorisation Applications (MAAs) , predominantly for generic pharmaceutical products.

The Role

As a Regulatory Medical Writer, you will:

• Prepare clinical and non-clinical overviews and summaries from literature and bioequivalence data
• Support product variations, renewals, and clinical updates
• Collate supporting bibliographies for CTD dossiers (Modules 4 and 5)
• Interpret and summarise complex scientific data with accuracy and clarity
• Ensure compliance with EMA, FDA, ICH and GCP guidelines
• Partner with subject matter experts and clients to align regulatory strategy and documentation
• Manage timelines, revisions, and version control across multiple projects

About You

We are seeking someone with:

• A degree in Life Sciences, Pharmacy, Medicine, or related discipline (advanced degree preferred)
• Prior regulatory medical writing experience
• Strong knowledge of bioequivalence, biowaivers, and bridging studies
• Proven track record in authoring Modules 2.4 & 2.5, plus bibliographic collation
• Excellent communication skills and client-facing confidence
• Ability to balance scientific rigour with pragmatic, solution-driven thinking

This is a fantastic opportunity to develop your career in regulatory writing within a consultancy that values innovation, expertise, and people.

Apply today or reach out to Gareth Gooley on to find out more

Our client is seeking a highly motivated and experienced Client Services Manager to join their dynamic team. As the Client Services Manager, you will play a crucial role in supporting the Business Development team by managing proposal generation and pricing activities, ensuring a seamless transition of signed opportunities into operations, and providing ongoing support to the wider team.

In this pivotal position, you will be responsible for facilitating the preparation of technical proposals, working closely with the Business Development team and Operations subject matter experts. This will involve crafting compelling commercial value propositions, developing clear scientific strategies, and tailoring materials to meet the specific needs of potential and existing clients. Additionally, you will be responsible for accurate proposal pricing, aligning with standard price lists and addressing project-specific Business Development pricing strategies.

To succeed in this role, you must possess excellent communication skills, the ability to develop and maintain positive relationships with both internal and external stakeholders. Strong organisational skills and the capacity to prioritize multiple projects concurrently while meeting deadlines are essential. The ideal candidate will also demonstrate analytical abilities to process and analyse business data and research, as well as exceptional writing skills and attention to detail.

This could also be the perfect opportunity for someone with pharmaceutical manufacturing industry experience who is looking to move into a more commercially focused role.

Key Responsibilities:

• Facilitate the preparation of technical proposals, including commercial value proposition, scientific strategy, and tailored materials
• Ensure accurate proposal pricing, working closely with Operations experts and addressing project-specific Business Development strategies
• Coordinate internal calls to develop proposals and obtain the necessary information for client-friendly submissions
• Attend client meetings and calls to support proposal construction and pricing
• Assist the Business Development team with prospect identification and opportunity management
• Facilitate the formal handover of new projects from Business Development to Operations
• Maintain accurate Salesforce records and ensure all opportunity documents are properly stored
• Identify process improvement opportunities and present them to the Head of Client Services

Qualifications and Skills:

• Degree in a relevant scientific discipline or equivalent industry experience
• Pharmaceutical manufacturing industry experience is preferred
• Excellent communication and interpersonal skills
• Strong time management and organisational abilities
• Proven track record of prioritising and managing multiple concurrent projects
• Ability to multi-task and handle changing priorities
• Analytical skills to process and analyse business data and research
• Exceptional writing skills and attention to detail
• Enthusiasm, proactivity, and a target-oriented mindset
• Relevant experience in a client-facing or proposal management role would be beneficial

This is a full-time, office-based position (37.5 hours per week). If you possess the required skills and experience and are excited to contribute to the success of this dynamic company, we encourage you to apply!

• Conduct site selection, initiation, monitoring, and close-out visits for clinical trials.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and all applicable regulations.
• Verify accuracy, completeness, and consistency of data recorded in case report forms (CRFs) and electronic data capture (EDC) systems.
• Monitor patient safety and report adverse events in a timely manner.
• Build and maintain strong working relationships with investigators and site staff.
• Provide training and ongoing support to clinical trial sites.
• Ensure all regulatory documentation is complete, accurate, and up-to-date.
• Manage study drug/device accountability and investigate any discrepancies.
• Prepare visit reports and follow up on action items.
• Collaborate with internal teams, including project managers and data management.

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role.
• Solid understanding of ICH-GCP guidelines and clinical trial processes.
• Experience in monitoring various therapeutic areas is a plus.
• Excellent organisational, time management, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to work independently and travel to clinical sites as required.
• Proficiency in using clinical trial management systems (CTMS) and EDC systems.
• Attention to detail and a commitment to data integrity and patient safety.
• Valid driver's license and willingness to travel.

• Lead and direct research projects focused on the discovery and development of novel pharmaceutical compounds.
• Design, develop, and execute complex experimental protocols and methodologies.
• Critically analyse and interpret large datasets, drawing scientifically sound conclusions.
• Author high-impact scientific publications and present research findings at international conferences.
• Contribute to the strategic direction of the research department and identify new research opportunities.
• Mentor and supervise a team of research associates and scientists, providing technical guidance and career development support.
• Collaborate effectively with cross-functional teams, including chemistry, biology, pharmacology, and regulatory affairs.
• Ensure compliance with all laboratory safety regulations and ethical guidelines.
• Manage research budgets and resources efficiently.
• Contribute to the filing of patent applications and the development of intellectual property.
• Stay current with the latest advancements in pharmaceutical research and relevant scientific fields.
• Evaluate and implement new technologies and techniques to enhance research capabilities.
• Prepare comprehensive research reports and proposals for internal and external stakeholders.

• Ph.D. in Pharmacology, Biochemistry, Molecular Biology, or a closely related field.
• A minimum of 10 years of post-doctoral research experience in the pharmaceutical or biotechnology industry.
• Demonstrated success in leading independent research projects and a strong publication record in peer-reviewed journals.
• Expertise in one or more key areas of drug discovery (e.g., target identification, lead optimisation, assay development, in vivo pharmacology).
• Proven experience in mentoring and managing scientific teams.
• Exceptional analytical, problem-solving, and critical thinking skills.
• Strong understanding of regulatory requirements in drug development (e.g., FDA, EMA).
• Excellent written and verbal communication skills, with the ability to present complex scientific information clearly.
• Proficiency in relevant scientific software and data analysis tools.
• Experience in therapeutic areas such as oncology, immunology, or neuroscience is advantageous.

• Lead the formulation development of new drug candidates, including solid dosage forms, injectables, or other relevant delivery systems.
• Design and execute experiments to investigate formulation strategies and optimize drug product performance.
• Characterize raw materials and finished drug products using various analytical techniques (e.g., HPLC, dissolution testing, DSC, XRD).
• Develop and validate analytical methods for formulation assessment.
• Troubleshoot formulation challenges and identify root causes.
• Prepare technical reports, documentation for regulatory submissions, and presentations.
• Collaborate with cross-functional teams to ensure alignment on project goals.
• Stay current with scientific literature and emerging trends in pharmaceutical formulation and drug delivery.
• Contribute to patent applications and scientific publications.
• Mentor junior scientists and provide technical guidance.

• Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
• Minimum of 5 years of experience in pharmaceutical formulation development.
• Hands-on experience with various dosage forms (e.g., tablets, capsules, injectables, topical).
• Proficiency in a wide range of pharmaceutical analytical techniques.
• Strong understanding of drug delivery principles, excipient science, and manufacturing processes.
• Excellent experimental design and data analysis skills.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Experience with CMC documentation for regulatory submissions is a plus.

• Design, develop, and optimise pharmaceutical formulations for various dosage forms (e.g., oral solids, injectables, topical).
• Conduct pre-formulation studies, including API characterisation and excipient compatibility.
• Develop and validate analytical methods for formulation characterisation and quality control.
• Perform stability studies and interpret data to determine product shelf-life.
• Prepare technical documentation for regulatory submissions (e.g., IND, NDA).
• Collaborate with analytical development, process development, and manufacturing teams.
• Troubleshoot formulation-related issues during development and scale-up.
• Mentor junior scientists and contribute to a collaborative research environment.
• Stay updated on industry trends, regulatory guidelines, and new technologies in pharmaceutical formulation.
• Manage external collaborations with contract research organisations (CROs).