Biotechnology, Pharmaceutical, Artificial Intelligence, Drug Discovery

Associate Director, Regulatory Affairs

Vancouver, BCOnsiteFull TimeDirectorCA$145,000–CA$180,000 /yrPosted 14 days ago

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Required skills

biologics
monoclonal antibody
drug development
regulatory agencies
IND
CTA
NDA
BLA
FDA
EMA

Nice to have

analytical mind
interpret clinical data
interpret nonclinical data
cross functional teams
communication skills
scientific mentorship

Role summary

AbCellera is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and submissions for innovative biologics-based therapeutics. This role involves serving as the primary liaison with regulatory authorities (FDA, EMA, Health Canada) and providing expert guidance throughout the product lifecycle. The ideal candidate will have extensive experience with IND/CTA to NDA/BLA submissions, particularly in monoclonal antibody and biologics development, with at least 8-10 years of RA experience in the biotech or pharmaceutical industry. Strong analytical, interpersonal, and communication skills are essential for collaborating with cross-functional teams and managing external consultants.

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

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. If you are a regulatory professional who wants to help move novel biologics from the lab to patients, we’d love to hear from you.

How you might spend your days

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

We’d love to hear from you if

You have extensive experience with submissions and interactions with FDA, EMA, Health Canada, and other major regulatory agencies

You have experience with all phases of drug development from IND/CTA to NDA/BLA, with an emphasis in monoclonal antibody/biologics drug development

You have at least 8-10 years of RA experience in the biotech or pharmaceutical industry; experience supporting biologics programs is strongly preferred

You have an analytical mind and have a demonstrated ability to analyze and interpret clinical and nonclinical data

You thrive working in cross functional teams

You have a strong understanding of international regulatory guidelines, GxP, the drug development process, regulatory designations, compliance, and industry standard practices

You have excellent interpersonal skills, organizational skills, and communication skills

What we offer

AbCellera’s hiring range for this role is CAD $145,000 - $180,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

To apply

Please submit your application through our website and refer to Job ID 23423 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

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Associate Director, Regulatory Affairs

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