Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within our Contract Manufacturing & Development Organization (CDMO)
Job Summary
Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within our Contract Manufacturing & Development Organization (CDMO).
Engage in Global Q/RA initiatives, improve site & product compliance to the latest regulatory standards, and promote regulatory services to support business growth.
Interact with key Customers & Regulatory Agencies to develop and implement regulatory strategies while ensuring successful experience & high reputation.
Matching Summary
Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within our Contract Manufacturing & Development Organization (CDMO).
Skills & Requirements
Must-have
EU & APAC regulatory landscape
large molecule drug substance
GMP manufacturing operational exposure
regulatory strategy development
customer and regulatory agency interaction
regulatory intelligence monitoring
Nice-to-have
multicultural and multidisciplinary teams
business growth trajectory support
creative business models
IT agility
discretion and independent judgement
Key Requirements
Minimum 15 years of relevant pharmaceutical regulatory affairs
Advanced Degree or equivalent experience in European Life Science
Previous CDMO experience is a competitive advantage