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Director – CMC RA New Modalities
ManpowerWrocław, dolnośląskie, Polska4 dni temu
Opis pracyDegree 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 remote work opportunities
Director – CMC RA New Modalities
Miejsce pracy : Wrocław
Your responsibilities
- 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
Employer requirements
What employer offers
Benefits
Manpower
Manpower 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!
Agencja zatrudnienia nr 412.
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Director • Wrocław, dolnośląskie, Polska