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