Associate Director, CMC Regulatory Affairs
AbCellera(22 hours ago)
About this role
AbCellera is seeking an Associate Director of CMC Regulatory Affairs to develop and implement global strategies for biologics programs, ensuring regulatory compliance and timely submissions. The role involves collaboration across teams and with external partners to support innovative biologics development.
Required Skills
- Regulatory Writing
- CMC
- Biologics
- FDA
- EMA
- Health Canada
- eCTD
- NDAs
- Vials
- Analytical Development
Qualifications
- 12 years relevant work experience
- Post-secondary degree in biological, pharmaceutical, chemical, or engineering sciences
About AbCellera
abcellera.comAbCellera is a biotechnology company that discovers and develops therapeutic antibodies using a proprietary high-throughput single‑cell screening platform combined with machine learning and large immune datasets. It partners with pharma and biotech to rapidly identify and optimize antibody leads and also advances its own pipeline of first‑in‑class and best‑in‑class programs across multiple indications and modalities. The platform is designed to accelerate target‑to‑candidate timelines and has been used in rapid-response collaborations and clinical‑stage antibody programs.
View more jobs at AbCellera →Apply instantly with AI
Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.
More jobs at AbCellera
Similar Jobs
Senior Director CMC Regulatory Affairs
IMVT Corporation(3 days ago)
Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals(12 days ago)
Associate Director, Regulatory Affairs CMC
Crinetics Pharmaceuticals(1 day ago)
Director, CMC Regulatory Affairs
Capricor Therapeutics(24 days ago)
Associate Director, Regulatory Affairs, CMC
BeOne Medicines(15 days ago)
Senior Director, Regulatory Affairs CMC
Alcon(18 days ago)