The Associate Director, Regulatory CMC, will execute global regulatory CMC strategies in collaboration with key stakeholders
Job Summary
The Associate Director, Regulatory CMC, will execute global regulatory CMC strategies in collaboration with key stakeholders.
You will provide expert guidance to manufacturing and quality teams, lead global regulatory submissions, and act as primary liaison with Health Authorities for CMC aspects of programs.
This is 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.
Skills & Requirements
Must-have
global regulatory CMC strategies
biologics and drug/device combination products
Health Authority interactions
biopharmaceutical regulations
Nice-to-have
collaboration with external experts
departmental initiatives
building a culture of core principles
Key Requirements
Bachelor's degree and 8+ years of experience in Regulatory CMC for biotherapeutics
Experience with biologics (monoclonal antibodies, bispecifics, fusion proteins, or vaccines)
Demonstrated track record of successful interactions with FDA and other Health Authorities
Preparation of Quality sections of regulatory dossiers (IND/CTA/IMPDs, BLA/MAAs)