mazowieckie / Warszawa
Senior Principal RA Scientist
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!
Senior Principal RA Scientist
Miejsce pracy: Warszawa
Nr Ref.: 20193
Job Tasks:
Permanent job offer.
- Collaborate with global teams to develop and execute CMC regulatory strategies for pharmaceuticals, devices, and advanced therapies
- Coordinate global submission plans aligned with local regulatory requirements
- Oversee preparation and submission of regulatory dossiers to health authorities
- Lead responses to health authority inquiries and internal strategy alignment
- Manage key initiatives within CMC Regulatory Affairs and support due diligence/licensing activities
- Provide guidance to team members and promote compliance with regulatory standards
- Represent CMC Regulatory Affairs in cross-functional teams and act as a regulatory expert
- Ensure regulatory strategies align with global regulatory affairs, therapeutic areas, commercial functions, and Quality Target Product Profile (QTPP)
- Maintain communication with Therapeutic Area Regulatory Affairs to ensure strategic alignment
- Refine regulatory strategies based on new data and escalate critical issues as needed
- Develop contingency plans for risks related to registration and compliance
- Communicate effectively with health authorities and lead meetings when appropriate
- Review regulatory dossiers and assess changes in chemistry, manufacturing, and control throughout product lifecycle
- Degree in biological, pharmaceutical, chemical, or engineering sciences; minimum 10 years’ experience in pharmaceutical or healthcare industry
- Ability to communicate regulatory requirements clearly
- Knowledge of biology, chemistry, or engineering relevant to pharma
- Experience developing regulatory strategies and product development
- Attention to detail and strong communication skills
- Ability to work cross-functionally and present regulatory strategies
- Experience interacting with Health Authorities
- Knowledge of global regulations and industry competitors
- 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
- Benefits package including healthcare, sports card, and insurance
Permanent job offer.