Associate Director, Regulatory Affairs
$145k - $180k per yearAbCellera
Associate Director of Regulatory Affairs at a clinical-stage biotech firm focused on antibody-based therapeutics. The role involves developing global regulatory strategies, managing CTA/IND submissions, serving as regulatory expert to program teams, and coordinating with regulatory agencies across the product lifecycle.
Responsibilities
- Develop and implement regulatory strategies for pipeline programs to accelerate development and identify risks
- Create and oversee regulatory submissions with appropriate content in collaboration with clinical and nonclinical teams
- Serve as primary regulatory expert to project teams on guidance documents and policy changes
- Interact with regulatory agencies and oversee meetings, discussions, and negotiations
- Manage external regulatory consultants and vendors for assigned programs
Requirements
- 8–10 years of regulatory affairs experience in biotech or pharmaceutical industry
- Extensive experience with FDA, EMA, Health Canada, and other major regulatory agencies
- Experience across all drug development phases from IND/CTA to NDA/BLA, with emphasis on monoclonal antibodies and biologics
- Ability to analyze and interpret clinical and nonclinical data
- Strong knowledge of international regulatory guidelines, GxP, and compliance standards
- Cross-functional collaboration and interpersonal skills
- Excellent written and verbal communication and organizational abilities
Compensation: CAD $145,000–$180,000 base annually
Vacancy posted 3 days ago
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