15+ years pharmaceutical regulatory affairs experience
Large molecule drug substance expertise
Eu and apac regulatory landscape knowledge
This leadership role supports regional matrix expansion to strengthen Regulatory Compliance and Services for Drug Substances and Products within the CDMO
Job Summary
This leadership role supports regional matrix expansion to strengthen Regulatory Compliance and Services for Drug Substances and Products within the CDMO.
The incumbent will manage a network of five sites across Europe and APAC, overseeing regulatory talent strategies, compliance duties, and major inspection preparedness.
Key responsibilities include enhancing regulatory services offerings, driving revenue generation through new business models, and leading critical regulatory quotations and application filings.
Matching Summary
This leadership role supports regional matrix expansion to strengthen Regulatory Compliance and Services for Drug Substances and Products within the CDMO.
Skills & Requirements
Must-have
15+ years pharmaceutical regulatory affairs experience
Large molecule drug substance expertise
EU and APAC regulatory landscape knowledge
cGMP manufacturing operational exposure
Matrix management of multi-site teams
CMC technical dossier writing capability
Nice-to-have
Previous CDMO industry experience
Proficiency in additional languages
Experience with digital transformation initiatives
Active participation in professional associations
Strong negotiation and influencing skills
Key Requirements
Advanced Degree in Life Sciences or equivalent
Minimum 15 years relevant regulatory affairs experience