Regulatory Clinical Trial Application Submission Manager

2 tygodni temu

Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat
Regulatory Clinical Trial Application Submission ManagerRegulatory Clinical Trial Application Submission Manager

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)
  • Practical 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)
  • International and interdisciplinary cooperation
  • Access to company's know how and opportunities for professional development
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

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)
  • Practical 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.
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