Senior Principal RA Scientist.

Opis stanowiska

podany przez pracodawcę :

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!

Job Tasks :

• 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

Requirements :

Offer :

Permanent job offer.