Regulatory Writer

About the CompanyA pioneering clinical-stage biopharmaceutical company is developing cell and gene therapies that aim to redefine treatment options for oncology and hematology patients worldwide.With a strong foundation in CAR-T and other advanced therapy medicinal products (ATMPs), the organization combines cutting-edge science with world-class manufacturing expertise to make personalized medicine accessible and scalable.The OpportunityThis is an exceptional opportunity for an experienced Regulatory Writer to play a key role in global submission and documentation activities for novel CAR-T and cell therapy programs. You’ll work within a collaborative Regulatory Affairs and Medical Writing team supporting pivotal trials and marketing authorization efforts across Europe and the U.S.The role combines scientific depth with regulatory precision, offering both strategic visibility and hands-on authorship.Key ResponsibilitiesAuthor and review high-quality regulatory and clinical documents, including:Clinical Study Reports (CSRs)Investigator’s Brochures (IBs)Clinical ProtocolsDevelopment Safety Update Reports (DSURs)Briefing Books and regulatory meeting materialsCommon Technical Document (CTD) modules (2.5, 2.7.3, 2.7.4)Translate complex oncology and hematology clinical data into clear, compliant, and scientifically sound documents.Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Quality teams.Ensure accuracy and alignment with EMA, FDA, and ICH regulatory requirements.Support documentation for scientific advice meetings, clinical trial applications, and marketing submissions.Contribute to continuous improvement of writing standards, templates, and processes.Provide guidance or mentorship to junior medical writers as the team expands.What We’re Looking ForAdvanced degree in Life Sciences (PhD, MSc, or equivalent).Proven experience as a Regulatory or Medical Writer within biopharma, ideally focused on cell and gene therapy, CAR-T, oncology, or hematology.Solid understanding of CTD/eCTD structure and core clinical/regulatory documentation.Strong working knowledge of ICH, EMA, and FDA standards.Excellent English writing and communication skills with scientific accuracy and clarity.Organized, self-motivated, and comfortable working independently.Ability to work on-site in the Cologne region approximately once per week.Why ApplyBe part of a mission-driven company delivering next-generation therapies that transform lives.Contribute to late-stage CAR-T and cell therapy programs with real clinical impact.Hybrid flexibility with an inclusive, science-led culture.Career growth potential, including leadership development as the team expands.Interested in this position? Apply now!✉ caustin@barringtonjames.com ☎ +44 (0) 1293 776644