Regulatory Submissions Specialist

Résumé du poste

The Regulatory Submissions Specialist will lead the electronic publishing, formatting, and compilation of clinical development submissions to ensure compliance with global regulatory standards. They will coordinate publishing projects, perform quality checks, and manage submission documentation while optimizing internal workflows.

Détails du poste

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.

Ce que vous ferez

The Regulatory Submissions Specialist will lead the electronic publishing, formatting, and compilation of clinical development submissions to ensure compliance with global regulatory standards. They will coordinate publishing projects, perform quality checks, and manage submission documentation while optimizing internal workflows.

Exigences

Candidates must have at least 5 years of experience in regulatory operations and proficiency with eCTD publishing and the Veeva RIM system. A Bachelor's degree is required, though equivalent experience may be considered in its absence.

Avantages

• Equity • Annual bonus • RRSP contribution • Active lifestyle allowance • Annual vacation • Professional development opportunities • Health benefits

Compétences indiquées

• Project Coordination · Souhaitée
• Assurance qualité · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Regulatory submissions
• Electronic publishing
• eCTD
• Veeva RIM
• Submission gateway
• Agency portals
• Regulatory operations
• Clinical development
• Compliance strategy
• Version control
• Quality assurance
• Project coordination
• Regulatory affairs
• Technical compliance
• Veeva
• Regulatory Affairs
• Courage
• Governance and Compliance Strategy
• Workflow Management
• Planning
• Biotechnology
• Pre-Clinical Development
• Immunology
• Version Control
• Communication
• Electronic Common Technical Document
• Digital Publishing
• Endocrinology
• Oncology
• Mentorship
• Operations
• Tenacity
• Timelines
• Detail Oriented

Domaines d’emploi

• Healthcare
• Science & Research
• Administrative
• Regulatory Submission Specialist
• Regulatory Affairs Specialist
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Specialists
• Compliance Officers