The posting
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.
