Overview
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.
Responsibilities
* 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
Qualifications
* 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
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