Regulatory Affairs Manager

Key Responsibilities

• Review nonclinical and laboratory-based regulatory documents, including toxicology and safety pharmacology study reports, in vitro and in vivo pharmacology reports, bioanalytical method validation and sample analysis reports, and toxicokinetic summaries, in preparation for IND, IMPD, IB, and BLA / MAA submissions.
• Quality-check written and tabulated summaries, and support compilation and traceability of the underlying study reports (Module 4, 2.6 etc) .
• Build preclinical data into coherent regulatory narratives. Working closely with laboratory scientists, bioanalysts, and the Clinical Regulatory Manager to connect nonclinical findings to the clinical development story.
• Collaborate cross-functionally with Research, CMC/Analytical, Regulatory Affairs, and Medical Writing to ensure scientific integrity, traceability, and timely delivery of submission materials.
• Interface with external suppliers and vendors including reviewing draft reports for accuracy, consistency, and regulatory fitness.
• Maintain accuracy and traceability by linking raw laboratory data, analyses, and summary-level interpretations throughout the reporting process.

Requirements

• Location: France (strong preference) but open to wider Europe.
• Laboratory presence: This role requires 4 to 5 days per month on site in the laboratory near Paris. Candidates must be able and willing to travel for this on a consistent monthly basis.
• Hands-on laboratory experience within biotech or pharma, with exposure to writing or reviewing scientific and study documentation.
• Familiarity with nonclinical or bioanalytical documentation such as toxicology study reports, pharmacology reports, method validation reports, or CTD Module 2.6 summaries. Direct regulatory writing experience is an advantage but not essential for those with a strong lab report background.
• Understanding of biologics development. Experience with fusion proteins, antibodies, or other protein therapeutics is strongly preferred, including familiarity with immunogenicity/ADA and potency assay concepts.
• Oncology or immunology experience preferred but open to all indications.
• Working knowledge of GLP principles and of ICH M3 / S6 guidance is an advantage.
• Collaborative and detail-oriented, comfortable working cross-functionally with scientists, analysts, and regulatory colleagues in an international team.
• Fluent English (written and spoken); French or German is an advantage.

Note - I listed Remote in the advert though technically this is Hybrid. Linkedin only allows Remote roles to be listed as Country wide.

Offer

• Flexible Contract: This can be Full-Time (38 Hours) or 80% (30 Hours)
• Hybrid: 80% working from home - the remaining 20% engaging with colleagues and staying close to the lab/science.
• True biotech culture – collaborative, supportive, and scientifically driven.
• Impactful mission – contribute to a potential first-in-class cancer therapy nearing market submission.

Interview Process

• Speak with me first - ensure its a good fit for you + 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. Making sure this is a good fit at every stage and this is the right career move for you (and your family).