The Associate Director, Regulatory CMC will execute global regulatory CMC strategies in collaboration with key stakeholders, providing expert guidance to manufacturing and quality teams
Job Summary
The Associate Director, Regulatory CMC will execute global regulatory CMC strategies in collaboration with key stakeholders, providing expert guidance to manufacturing and quality teams.
Key responsibilities include leading global regulatory submissions, acting as primary liaison with Health Authorities for CMC aspects, and interpreting applicable regulations to ensure CMC compliance.
This role offers a unique opportunity to join a growing organization with an expanding pipeline and play an integral role in the creation and implementation of regulatory strategies from early development through marketing approval.
Matching Summary
The Associate Director, Regulatory CMC will execute global regulatory CMC strategies in collaboration with key stakeholders, providing expert guidance to manufacturing and quality teams.
Skills & Requirements
Must-have
global regulatory CMC strategies
biologics experience required
monoclonal antibodies
bispecifics
fusion proteins
vaccines
drug/device combination products
Nice-to-have
proactive regulatory intelligence
collaborate effectively with experts
fast-paced dynamic environment
Key Requirements
Bachelor's degree and 8 years of experience
Demonstrated track record with FDA/Health Authorities
Expert understanding of scientific principles and regulatory CMC
Preparation of Quality sections of regulatory dossiers
Preparation for and conduct of Regulatory CMC meetings