Director – CMC RA New Modalities

Job title:

Director – CMC RA New Modalities

Company:

Manpower

Job description

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.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!

Expected salary

Location

Warszawa, mazowieckie

Job date

Sun, 29 Jun 2025 01:15:37 GMT

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