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
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