Manager Regulatory Affairs 100% (f/m/d)
Remote · Germany
Job Summary
Senior Regulatory Affairs Manager responsible for leading regulatory strategy and lifecycle activities across US, EU, JP, CN, and BR markets. Manage regulatory representation in projects from pre-clinical to marketed products; coordinate cross-functional teams; develop tailored regulatory strategies; provide regulatory guidance to internal and external stakeholders; hands-on writing/review of regulatory documents/dossiers (including life-cycle management, NDA, and drug substance CMC sections); coordinate responses to authority requests; drive site-wide initiatives for improvement and innovation; coach RA members and contribute to knowledge transfer; requires Master’s degree or PhD in natural sciences and 5+ years RA experience; English fluency is required, German a plus; offer includes flexible hours with home office days and development opportunities.
Required Qualifications
- Master or PhD in Natural Sciences (Chemistry, Pharmacy or similar)
- At least 5 years of professional experience in Regulatory Affairs
- Experience with regulatory requirements for drug substances is a plus
- Strong communication and collaboration skills with internal stakeholders, customers, and regulatory agencies
- Experience in supervising complex projects and establishing regulatory strategies
- Flair for high-quality output including regulatory dossiers, CMC sections, and presentations
- Fluent and persuasive in English (C1); German is a plus
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