Regulatory Submissions Specialist

AbCellera; Vancouver; On-site; CAD 93,000 - 116,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active lifestyle allowance

Health benefits

Professional development

Job summary

AbCellera is seeking a meticulous Regulatory Submissions Specialist to lead electronic publishing of clinical development submissions. You will format, compile, and ensure compliance across global health authorities, coordinating with internal stakeholders to meet tight timelines.

You’ll apply 5+ years in regulatory operations, a Bachelor’s degree, and strong experience with eCTD, Veeva RIM, submission gateways, and regulatory processes to ensure high-quality submissions and seamless lifecycle

Qualifications

• 5+ years experience in regulatory operations or equivalent.
• Bachelor's degree required; equivalents considered.
• Experience with eCTD publishing (CTAs, INDs, BLAs/NDAs).
• Extensive experience with Veeva RIM and submission portals.
• Strong understanding of Regulatory Affairs processes and submission lifecycle.
• Highly organized with a methodical approach and attention to detail.

Responsibilities

• Compile, publish, and validate regulatory submissions per health authority requirements.
• Support regulatory submissions across US, Canada, Australia, EU, and other regions.
• Ensure accuracy and technical compliance of published submissions.
• Coordinate publishing projects with internal stakeholders and timelines.
• Perform quality checks and address validation findings before submission.
• Maintain submission documentation and version control.

Skills

eCTD publishing

Regulatory operations

Veeva RIM

Submission portals

Attention to detail

Organization

Education

Bachelor's degree

Tools

Veeva RIM

Submission gateway

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.