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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