Senior CMC Regulatory Affairs Manager

Résumé du poste

The Senior CMC Regulatory Affairs Manager will lead the planning, authoring, and execution of global CMC regulatory submissions for biologics programs. They will also provide strategic guidance to cross-functional teams to ensure compliance with global health authority requirements.

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 at the edge of the unknown, and go one step beyond. We are seeking a Senior CMC Regulatory Affairs (RA) Manager who will work closely with our Manufacturing and Quality teams to implement and document global CMC strategies for multiple biologics programs, from pre-clinical development through Phase 3 studies and commercialization. You will be a key member of cross-functional project teams, helping to shape the CMC regulatory strategy and documentation for innovative new biologics and ensuring submissions are aligned with global health authority requirements and delivered on time with quality. How you might spend your days Leading the planning, authoring, review, and execution of global CMC regulatory submissions, including health authority briefing documents, Module 3 content for INDs, IMPD/QOS, CTAs, and other regulatory filings Leading or contributing to the development of responses to health authority queries Providing strategic CMC regulatory guidance and critical review of technical documentation, including validation protocols and reports, to ensure CMC strategies and supporting data are scientifically sound, compliant with global regulatory expectations, effectively presented within high-quality regulatory submissions Managing critical CMC regulatory timelines and deliverables, partnering closely with Manufacturing, Quality, and Analytical Development teams to support development and registration objectives Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs Identifying regulatory CMC program risks, assessing potential impact to development programs, and establishing mitigation strategies Assessing CMC change controls for regulatory impact and ensuring ongoing compliance with global regulatory filings Partnering with CMC, Discovery, Quality, and Clinical Development teams to innovate strategies to accelerate submission timelines and work as a key member of project teams We’d love to hear from you if You have a deep understanding of CMC regulatory requirements, eCTD structure, and experience in Module 3 preparation and authoring (INDs/IMPDs and BLAs/NDAs/NDSs) for biologics and combination products You have experience developing and executing CMC regulatory strategies and submissions for biologics and combination products, including pre-filled syringes, auto-injectors, and other drug-device delivery systems, with a strong understanding of associated regulatory documentation requirements You have a thorough understanding of Health Canada, FDA, and EMA regulations You are a skilled regulatory professional and technical writer with effective oral communication skills You are a detailed-oriented individual, highly organized, and thrive in fast paced environments while managing multiple priorities. You hold an advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related sciences, plus about 8 years of relevant work experience What we offer AbCellera’s hiring range for this role is CAD $150,000 - $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 individual 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 23397 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 Senior CMC Regulatory Affairs Manager will lead the planning, authoring, and execution of global CMC regulatory submissions for biologics programs. They will also provide strategic guidance to cross-functional teams to ensure compliance with global health authority requirements.

Exigences

Candidates must have approximately 8 years of relevant experience in CMC regulatory affairs, specifically with biologics and combination products. A degree in biological, pharmaceutical, chemical, or engineering sciences is required, along with deep knowledge of eCTD structures and global regulatory environments.

Avantages

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

Compétences indiquées

• Assurance qualité · Souhaitée

Autres compétences pertinentes

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

• CMC regulatory strategy
• Biologics
• Regulatory submissions
• Technical writing
• Module 3 preparation
• eCTD
• IND
• BLA
• NDA
• Health authority interaction
• Change control
• Risk assessment
• Quality assurance
• Analytical development
• Drug-device delivery systems
• Regulatory Affairs
• Regulatory Documents
• Courage
• Regulatory Environment
• Network Quality Of Service (QoS)
• Regulatory Intelligence
• Combination Products
• Validation Protocols
• Regulatory CMC
• Planning
• Biotechnology
• Biology
• Biopharmaceuticals
• Change Control
• Chemical Engineering
• Pre-Clinical Development
• Immunology
• Commercialization
• Communication
• Distributed Control Systems
• Electronic Common Technical Document
• Endocrinology
• Innovation
• Injector
• Oncology
• Mentorship
• Pharmaceuticals
• Technical Documentation
• Tenacity
• Timelines
• Verbal Communication Skills
• Regulatory Filings

Domaines d’emploi

• Healthcare
• Science & Research
• Manufacturing
• Management & Leadership
• CMC Regulatory Affairs Manager
• Regulatory Affairs Manager
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Managers
• Managers, All Other