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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
