Regulatory Medical Writer - Pharmaceuticals

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