From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter.
We are looking for a regulatory affairs leader to join our team. You will be responsible for developing and implementing global regulatory strategies and submissions from CTA/IND to NDA/BLA across AbCellera’s portfolio of innovative biologics-based therapeutics. You will serve as our primary liaison to global regulatory authorities and build a regulatory affairs team that can provide expert regulatory guidance on nonclinical, clinical, and manufacturing issues throughout a product’s life cycle.
How you might spend your days:
Building and leading the global regulatory affairs function with fit-for-purpose growth to support a growing pipeline
Developing regulatory strategies for all pipeline programs that highlight opportunities to accelerate development as well as identify regulatory risks and mitigation plans
Overseeing all regulatory submissions and ensuring appropriate content in collaboration with project teams as well as CMC, clinical, nonclinical, translational, and project management functions
Serving as the company’s primary expert on regulatory matters, including new guidance documents, policy changes, drug approval trends, and compliance matters for the Executive team and Board of Directors
Ensuring regulatory objectives are in line with target product profiles, business strategy, and corporate objectives
Acting as the primary point of contact for all regulatory agencies and overseeing all discussions, meetings, and negotiations
Developing and managing a regulatory affairs budget to appropriately resource activities to meet all regulatory objectives
Identifying and overseeing external regulatory consultants and vendors appropriate for each program
Effectively managing and mentoring your team
We’d love to hear from you if:
You have extensive experience 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 biologics drug development
You are analytical 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 are comfortable operating with incomplete information in a dynamic and fast-paced organization, adapting to shifting priorities across multiple programs
You have excellent interpersonal skills, organizational skills, and communication skills
You have at least 15 years of leadership experience in the biotech or pharmaceutical industry, with at least 12 years focused on regulatory affairs; experience building a regulatory affairs function is strongly preferred
Your primary working location is Vancouver (preferred) or California, and you are comfortable with a hybrid working environment; candidates based in other locations are welcome to apply
What we offer:
AbCellera’s hiring range for this role is $264,000 - $331,000 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/401K contribution.
You will have an annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find we prioritize teams and social groups to build community and connections across AbCellera.
About AbCellera:
AbCellera is a global company focused on delivering breakthrough medicines that alleviate suffering, extend lives, and improve health. Our platform includes fully integrated capabilities to create first-in-class and best-in-class antibody medicines, from discovery to clinical manufacturing.
We are using our technological advantage to develop programs across multiple indications including endocrine and metabolic conditions, oncology, and inflammation and autoimmunity. We’re advancing programs involving complex transmembrane proteins, bispecifics, and antibody drug conjugates.
Creating medicines is the most important work we can do. 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 23320 in your cover letter. We apologize in advance, but 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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