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Associate Director, Regulatory Affairs at AbCellera - ApplyBlast

Associate Director, Regulatory Affairs

AbCellera

3 days ago

3.6 on Glassdoor

Vancouver, British Columbia, Canada

Onsite

Full Time

Director

0 applicants

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About this role

The Associate Director, Regulatory Affairs leads global regulatory strategies and develops CTA/IND submissions for AbCellera's innovative biologics-based therapeutics. Serving as the primary contact with regulatory authorities, the role provides expert guidance on nonclinical and clinical issues throughout a product's life cycle. This position supports the translation of novel biologics from the lab to patients.

Responsibilities

Develop and implement global regulatory strategies for pipeline programs
Oversee CTA/IND and NDA/BLA submissions across biologics portfolio
Serve as primary contact with regulatory authorities and external consultants

Skills

About AbCellera

abcellera.com

Headquarters

Vancouver, British Columbia, Canada

Company Size

501-1000 employees

Founded

2012

View Profile

AbCellera 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.