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Principal Scientist CMC RA.

Principal Scientist CMC RA.

ManpowerGroupWarszawa
1 day ago
Job description

Opis stanowiska

podany przez pracodawcę :

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

Requirements :

  • 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
  • Offer :

  • 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
  • Permanent job offer.

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    Principal Scientist Cmc Ra • Warszawa