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Director – CMC RA New Modalities
  • Warszawa
Director – CMC RA New Modalities
Warszawa, Warszawa, Mazowieckie, Polska
ManpowerGroup Sp. z o.o.
28. 6. 2025
Informacje o stanowisku

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:

  • Lead and manage CMC RA teams responsible for global regulatory strategy in new modalities
  • Collaborate with senior leadership to develop organizational strategies, policies, and standards
  • Plan, organize, and direct resources and activities within CMC RA to ensure timely execution of projects
  • Oversee preparation, review, and approval of regulatory dossiers for global health authority submissions
  • Serve as a subject matter expert and single point of contact (SPOC) on CMC regulatory affairs
  • Represent CMC RA in cross-functional governance committees and strategic meetings
  • Drive continuous improvement and ensure compliance with regulatory requirements and company standards
  • Develop contingency plans and manage risks related to product registration and lifecycle management
  • Lead interactions and maintain strong professional relationships with health authorities worldwide
  • Support due diligence, licensing evaluations, and strategic business initiatives
  • Provide coaching, training, and development for team members to build a high-performing organization
Requirements:
  • Degree in biological, pharmaceutical, chemical, or engineering sciences; MS, PhD, or PharmD preferred
  • Minimum 12+ years of relevant experience in pharmaceutical or healthcare industry with leadership experience
  • Proven track record in developing and implementing global CMC regulatory lifecycle strategies, particularly for new modalities
  • Strong knowledge of biology, chemistry, engineering, and global regulatory frameworks
  • Excellent communication, interpersonal, and decision-making skills
  • Experience leading global health authority interactions and regulatory negotiations
  • Ability to work in a matrix environment and influence senior leadership
  • Demonstrated leadership skills in managing teams and driving strategic initiatives
Offer:
  • Opportunity to work for a global pharmaceutical company
  • Stable and supportive work environment
  • Option for 100% remote work within Poland
  • Work primarily in English
  • Competitive salary and benefits package


Permanent job offer.

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