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!
Regulatory Clinical Trial Application Submission Manager
Miejsce pracy: Warszawa
Nr Ref.: 2945
Duties:
- Manages regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 – Phase 4 spanning the therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease)
- Ensures that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
- Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
- The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
Requirements:
- Educational backround within life science area (pharmaceuticals, biotechnology, biology, chemistry)
- Minimum 6 years of experience within regulatory affairs in the pharmaceutical industry in clinical trials submisions
- Practical experience within clinical trails area
- Understanding of Drug Development, Clinical Trial Authorization Applications and associated legal requirements is also a must
- Advanced English communication skills (C1)
- Strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
- Strong impact and influencing skills
Offer:
- Amibious and challenging position in a company that is one of the global med-tech leaders (sponsor)
- Attractive salary
- International and interdisciplinary cooperation
- Access to company's know how and opportunities for professional development
- Remote work
Permanent job offer.