Health Regulatory Affairs Specialist m/w

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 right to the edge of the unknown, and go one step beyond.
We are looking for a meticulous Regulatory Submissions Specialist to spearhead the electronic publishing of our clinical development submissions. By leading the formatting, compilation, and compliance strategy across regional regulatory authorities, you will ensure our highest quality standards are met as we navigate complex global pathways.
Compiling, publishing, and validating regulatory submissions in compliance with health authority requirements
Supporting regulatory submissions across the US, Canada, Australia, the EU, potentially extending to other global regions
Ensuring accuracy, consistency, and technical compliance of published submissions
Coordinating and planning assigned publishing projects in collaboration with internal stakeholders
Performing quality checks and addressing validation findings prior to submission
You have 5+ years experience in regulatory operations, in addition to a Bachelor’s degree; You have extensive experience working in the Veeva RIM system, as well as submission gateway and agency portals in the context of regulatory operations
You have a good understanding of Regulatory Affairs processes and the submission lifecycle
You have strong attention to detail and a quality mindset
AbCellera’s hiring range for this role is CAD $93,000 - $116,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an 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 are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.
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.
That’s why we hire for character and intelligence, not just for CVs or experience.