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:

• Collaborate with global teams to lead Regulatory CMC activities supporting product development
  
  
• Develop and implement global CMC regulatory strategies for drugs, devices, vaccines, and gene/ cell therapies
  
  
• Prepare and review regulatory dossiers for Health Authority submissions
  
  
• Collaborate on global submission plans aligned with local regulatory requirements
  
  
• Participate in due diligence and licensing evaluations.
  
  
• Ensure compliance with company standards and update strategies based on new data
  
  
• Communicate effectively with Health Authorities and maintain strong professional relationships
  
  
• Identify and escalate risks related to product registration and regulatory compliance
  
  
• Review regulatory documents throughout the product lifecycle
  
  
• Provide regulatory guidance on chemistry, manufacturing, and control changes
  
  

• Degree in biological, pharmaceutical, chemical, or engineering sciences with 8+ years of relevant experience; advanced degree is a plus
  
  
• Strong regulatory knowledge and ability to communicate requirements effectively
  
  
• Solid background in biology, chemistry, or engineering related to pharma
  
  
• Proven experience in creating and implementing regulatory strategies
  
  
• Excellent communication and teamwork skills
  
  
• Experience working with Health Authorities
  
  
• Familiarity with global regulatory frameworks and submission procedures
  
  
• Understanding of competitor landscape in product development
  
  

• Opportunity to work for a global Big Pharma company
  
  
• Stable job environment
  
  
• Join an international, dynamic team and contribute to innovative projects in global markets
  
  
• Option for 100% remote work within Poland
  
  
• Work primarily in English 
  
  

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