Associate Director, Regulatory Affairs

We are looking for a Regulatory Affairs (RA) leader to join our growing team. You will implement global regulatory strategies and develop CTA/IND submissions across AbCellera's portfolio of innovative biologics-based therapeutics. As the primary point of contact with regulatory authorities, you will also provide expert regulatory guidance on nonclinical and clinical issues to program teams throughout a product's life cycle.

Responsibilities

Developing and implementing regulatory strategies for pipeline programs that highlight opportunities to accelerate development as well as identify regulatory risks and mitigation plans; Developing and overseeing regulatory submissions and ensuring appropriate content in collaboration with project teams as well as clinical, nonclinical, translational, and project management functions; Serving as the project team's primary expert on regulatory matters, including new guidance documents and policy changes; Interacting with regulatory agencies and overseeing discussions, meetings, and negotiations; Overseeing external regulatory consultants and vendors appropriate for assigned programs; Implementing global regulatory strategies and developing CTA/IND submissions across AbCellera's portfolio of biologics-based therapeutics; Serving as the primary point of contact with regulatory authorities; Providing expert regulatory guidance on nonclinical and clinical issues to program teams throughout a product's life cycle

Requirements

Extensive experience with submissions and interactions with FDA, EMA, Health Canada, and other major regulatory agencies; Experience with all phases of drug development from IND/CTA to NDA/BLA, with an emphasis in monoclonal antibody/biologics drug development; At least 8-10 years of RA experience in the biotech or pharmaceutical industry; experience supporting biologics programs is strongly preferred; An analytical mind with a demonstrated ability to analyze and interpret clinical and nonclinical data; Thrives working in cross functional teams; Strong understanding of international regulatory guidelines, GxP, the drug development process, regulatory designations, compliance, and industry standard practices; Excellent interpersonal, organizational, and communication skills

Benefits

Equity; Annual bonus dependent on team and company performance; 6% (non-match) RRSP contribution; CAD $1,500 annual Active Lifestyle Allowance; Annual vacation; Professional development opportunities; Comprehensive health benefits; Scientific and technical mentorship; Community, clubs, and socials