--- title: 'Regulatory Submissions Specialist at AbCellera' canonical: 'https://feeny.ai/job/regulatory-submissions-specialist-abcellera-vancouver-msy5mk9twr61' type: 'job' last_seen: '2026-09-11' --- # Regulatory Submissions Specialist at AbCellera - **Company:** AbCellera - **Location:** Vancouver, Canada - **Posted:** 2026-09-02 - **Last confirmed live:** 2026-09-11 - **Apply:** https://job-boards.greenhouse.io/abcellera/jobs/7984847003 ## Job description 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. ## How you might spend your days - 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 - Maintaining submission documentation and ensuring proper version control - Working effectively within defined timelines while managing multiple submissions - Developing and optimizing publishing workflows We’d love to hear from you if you - You have proven experience with eCTD publishing including CTAs, INDs and BLAs/NDAs - You have 5+ years experience in regulatory operations, in addition to a Bachelor’s degree; candidates with equivalent experience in absence of a post-secondary degree will also be considered - 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 are highly organized with a methodical approach to work - You have strong attention to detail and a quality mindset ## What we offer 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. ## 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 23389 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. ## About AbCellera ## Company Overview - **One-liner**: AbCellera is a clinical-stage biotechnology company that discovers and develops antibody-based medicines using an integrated platform from target identification through clinical manufacturing. - **Entity Type**: Public (Nasdaq: ABCL) - **Headquarters**: Vancouver, British Columbia, Canada - **Founded**: 2012 (based on “14+ Years” on corporate site) - **Founders**: Carl Hansen, PhD (Chairman, CEO & President); Véronique Lecault, PhD (Director, CTO) – originally six scientists from an academic lab ## Core Business - **Primary industry**: Biotechnology – antibody therapeutics - **Target customers**: B2B partnerships with biopharma companies (historically) and now also developing its own pipeline for patients - **Mission**: “To create a pipeline of innovative antibody medicines.” ## Products & Services - **Platform Technology**: A fully integrated antibody discovery and development platform combining microfluidics, single-cell analysis, computational biology, and protein engineering. Used to generate antibodies against complex targets (GPCRs, ion channels, multipass membrane proteins). - **ABCL635**: A first-in-class antibody for non-hormonal treatment of vasomotor symptoms (hot flashes) associated with menopause. Targets NK3R. Currently in Phase 1/2 clinical trial. - **ABCL575**: An investigational monoclonal antibody for moderate-to-severe atopic dermatitis, targeting OX40L with Fc-silencing and half-life extension. Phase 1 trial initiated Q3 2025. - **ABCL688**: An antibody medicine targeting a multipass complex membrane protein for an undisclosed autoimmune indication. Entered IND-enabling studies in Q2 2025. - **Partnership Business**: Completed 100+ discovery programs with 40+ partners since 2015, generating passive royalty stakes in partner drug programs. ## Market Standing - **Valuation/Market Cap**: Not publicly available from provided sources (public company; check Nasdaq: ABCL for current cap) - **Key Metric**: Public company with ~600 employees; 100+ programs delivered; internal pipeline moving into clinic - **Notable Investors/Partners**: Not specified in sources (as a public company, institutional investors are listed in SEC filings) - **Growth Signals**: Shift from pure partnership model to advancing internal pipeline; first internal program (ABCL635) reached Phase 1/2; new 130,000 sq ft GMP manufacturing facility in Vancouver; headcount growth from six scientists to ~600 ## Competitive Advantages - **Integrated platform** that covers the entire antibody development chain from target to clinical manufacturing, reducing handoffs and accelerating timelines. - **Proprietary microfluidics and single-cell analysis** technologies that enable high-throughput screening of natural immune responses. - **Deep expertise in difficult targets** (GPCRs, ion channels, multipass membrane proteins) that are challenging for traditional antibody discovery. - **Built over a decade of partnerships** – the platform was refined through 100+ partnered programs, creating a robust technology base. ## Strategic Focus - Transitioning from a technology-partnership company to a clinical-stage biotech advancing its own pipeline. - Prioritizing internal and co-development programs in endocrinology / women’s health, immunology & inflammation, and oncology. - Building in-house clinical manufacturing capabilities (CMC) to support GMP production of drug substance and drug product. ## Why Work Here - **Culture**: Values “truth and scientific rigor,” independent thinking, and courage to work at the edge of the unknown. - **Team focus areas**: Discovery, Data Science / ML / IT / Engineering, Clinical Manufacturing, Quality, and more. - **Perks & benefits**: - Comprehensive health benefits (medical, dental, life, critical illness) - Equity ownership (stock options/RSUs) - Retirement savings (RRSP/401K) with no employee match required (North America) - Minimum 3 weeks vacation plus 2 company-wide closures per year - Active lifestyle allowance - Immigration and relocation assistance - Personal & professional development (workshops, conferences) - World-class labs, offices, and on-site gym - **Work policy**: Likely on-site in Vancouver given lab and manufacturing roles; specific remote/hybrid options not detailed in provided sources. ## Sources 1. [abcellera.com](https://www.abcellera.com/) 2. [abcellera.com/about](https://www.abcellera.com/about) 3. [abcellera.com/careers](https://www.abcellera.com/careers) 4. [abcellera.com/current-openings](https://www.abcellera.com/current-openings) 5. 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