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 & Regulatory Services for Drug Substances & Drug Products within the Contract Manufacturing & Development Organization
Job Summary
This leadership role supports regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within the Contract Manufacturing & Development Organization.
The incumbent will mentor a community of site-based individuals while contributing to their progress and encouraging EU & APAC regulations knowledge applicable to large molecules within the Global Q/RA network.
Key responsibilities include monitoring major pharmaceutical regulations, improving internal regulatory knowledge through training, and enhancing regulatory services offering to drive revenue generation.
Matching Summary
This leadership role supports regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within the Contract Manufacturing & Development Organization.
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
Nice-to-have
Previous CDMO industry experience
Proficiency in additional languages
Experience with digital transformation initiatives
Strong negotiation and influencing skills
Active participation in professional communities
Key Requirements
Advanced Degree in Life Science or equivalent
Minimum 15 years relevant regulatory affairs experience
Intimate knowledge of EU regulatory landscape including GMP essentials