mazowieckie / Warszawa
Principal Scientist CMC RA
2025-06-27
Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!
Principal Scientist CMC RA
Miejsce pracy: Warszawa
Nr Ref.: 20198
Job Tasks:
Permanent job offer.
- Collaborate with global teams to lead Regulatory CMC activities supporting product development
- Develop and implement global CMC regulatory strategies for drugs, devices, vaccines, and gene/ cell therapies
- Prepare and review regulatory dossiers for Health Authority submissions
- Collaborate on global submission plans aligned with local regulatory requirements
- Participate in due diligence and licensing evaluations.
- Ensure compliance with company standards and update strategies based on new data
- Communicate effectively with Health Authorities and maintain strong professional relationships
- Identify and escalate risks related to product registration and regulatory compliance
- Review regulatory documents throughout the product lifecycle
- Provide regulatory guidance on chemistry, manufacturing, and control changes
- Degree in biological, pharmaceutical, chemical, or engineering sciences with 8+ years of relevant experience; advanced degree is a plus
- Strong regulatory knowledge and ability to communicate requirements effectively
- Solid background in biology, chemistry, or engineering related to pharma
- Proven experience in creating and implementing regulatory strategies
- Excellent communication and teamwork skills
- Experience working with Health Authorities
- Familiarity with global regulatory frameworks and submission procedures
- Understanding of competitor landscape in product development
- Opportunity to work for a global Big Pharma company
- Stable job environment
- Join an international, dynamic team and contribute to innovative projects in global markets
- Option for 100% remote work within Poland
- Work primarily in English
Permanent job offer.