Associate Director, Regulatory Affairs

The role

You will implement global regulatory strategies and develop CTA/IND submissions for biologics-based therapeutics. You will serve as the primary point of contact with regulatory authorities and provide expert guidance to program teams.

What you will do

• Developing and implementing regulatory strategies for pipeline programs
• Developing and overseeing regulatory submissions in collaboration with project teams
• Serving as the project team's primary expert on regulatory matters
• Interacting with regulatory agencies and overseeing discussions, meetings, and negotiations
• Overseeing external regulatory consultants and vendors

Required qualifications

• 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
• At least 8-10 years of RA experience in the biotech or pharmaceutical industry
• Ability to analyze and interpret clinical and nonclinical data
• Ability to work in cross functional teams
• Strong understanding of international regulatory guidelines, GxP, the drug development process, regulatory designations, compliance, and industry standard practices
• Excellent interpersonal skills, organizational skills, and communication skills

Nice to have

• experience supporting biologics programs

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

Before you apply

• Refer to Job ID 23423 in your cover letter
• Only selected candidates will be contacted for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.