Director – CMC RA New Modalities

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.