Principal Scientist CMC RA

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

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.