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 fanta...