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
  
  

• 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 
  
  

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