mazowieckie / Warszawa
Director – CMC RA New Modalities
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!
Director – CMC RA New Modalities
Miejsce pracy: Warszawa
Nr Ref.: 20199
Job Tasks:
Permanent job offer.
- 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
- 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
- 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.