(senior) Regulatory Writer

A leading European biotech company is seeking an experienced Regulatory / Scientific Writer to support the preparation of BLA and MAA submissions for a Phase III oncology program in 1st-line NSCLC. This hands-on position sits at the intersection of Clinical Pharmacology, Regulatory Affairs, and Medical Writing, focusing on PK / PD, ADA, and exposure–response documentation. You will author, integrate, and review critical clinical and regulatory reports that bridge preclinical and late-stage data into clear, submission-ready narratives. Ideal for a Senior Regulatory Writer, Clinical Pharmacology Writer, or Regulatory Documentation Scientist with strong attention to scientific detail, data integrity, and accuracy.

Key Responsibilities

• Author and review core regulatory documents — including population PK, exposure–response, PD, and ADA reports, as well as relevant Module 2 summaries — in preparation for IND, IB, and BLA / MAA submissions.
• Integrate preclinical and clinical data into coherent regulatory narratives. Work closely with Clinical Research Scientists, Biostatisticians, and Data Analysts to connect PK / PD / ADA analyses with late-stage clinical documentation.
• Translate complex datasets into clear, submission-ready documents that meet regulatory and internal scientific standards.
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and Medical Writing teams to ensure scientific integrity, traceability, and timely delivery of submission materials.
• Contribute directly to BLA / MAA preparation by compiling and integrating analyzed PK / PD / ADA data, writing integrated reports (e.g., IB updates, CTD Module 2 sections), and verifying consistency across all submission components.
• Maintain accuracy and traceability by linking raw data, analyses, and summary-level interpretations throughout the reporting process.

Requirements

• Location: Must be based in Germany, France, or the Netherlands. Relocation to these countries is fine but work visa sponsorship will not be offered at this stage. You must have a valid working permit in EU or aforementioned countries.
• Experience in regulatory or scientific writing within biotech or pharma, preferably supporting late-phase submissions (Phase II–III, BLA / MAA).
• Oncology experience strongly preferred (e.g., ORR per RECIST, PFS, OS endpoints); if no oncology then those with strong late-stage regulatory writing experience will also be considered.
• Understanding of PK, PD, and ADA data, with ability to interpret analyzed datasets and summarize findings for regulatory documentation.
• Familiarity with authoring documents such as: population PK reports, exposure–response analyses, integrated PD / ADA reports, Investigator’s Brochures (IB), and CTD Module 2 summaries.
• Collaborative and detail-oriented, comfortable working cross-functionally with scientists, statisticians, and regulatory colleagues in an international team.
• Fluent English (written & spoken); German or French is an advantage.
• Travel: 4x per year travel to the HQ (in Germany).

Offer

• Remote position – based anywhere in Germany, France, or the Netherlands.
• Flexible Contract: This can be Full-Time (38 Hours) or 80% (30 Hours).
• Salary: Base €73,000 - €92,000 - depending on background, contract type, etc.
• True biotech culture – collaborative, supportive, and scientifically driven.
• Impactful mission – contribute to a potential first-in-class cancer therapy nearing market submission.
• Title: Final title depending on level of relevant experience. Those with previous oncology BLA experience can command higher titles if desired.

Interview Process

• Speak with the recruiter first to ensure a good fit for you and the company.
• First Interview – with hiring manager
• Second Interview – with colleagues and team
• Final Interview – in-person interview
• Offer and discussions

I will support you in each part of the journey, ensuring this is a good fit at every stage and a solid career move for you and your family.

Contact

Human Led Recruitment (i.e. no AI involvement): I review every CV and will provide a short Yes/No note to applicants. Feel free to contact me directly at or connect on LinkedIn.

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