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Principal Scientist CMC RA.
ManpowerGroupWarszawa1 day ago
Job descriptionDegree 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
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 :
Offer :
Permanent job offer.
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Principal Scientist Cmc Ra • Warszawa