Senior Manager, CMC Regulatory Affairs

AbCellera•San Francisco, CA

11h

About The Position

The Senior Manager, CMC Regulatory Affairs works closely with 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. As a key member of cross-functional project teams, this person helps shape CMC regulatory strategies and documentation for new biologics and ensures submissions align with global health authority requirements and are delivered on time and with quality.

Requirements

Deep understanding of CMC regulatory requirements and eCTD structure, with experience preparing and authoring Module 3 content for biologics and combination product submissions, including INDs, IMPDs, BLAs, NDAs, and NDSs.
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, and a strong understanding of related regulatory documentation requirements.
Thorough understanding of Health Canada, FDA, and EMA regulations.
Strong regulatory professional and technical writing skills, with effective oral communication skills.
Detail-oriented, highly organized, and able to thrive in a fast-paced environment while managing multiple priorities.
Advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related science, plus about 8 years of relevant work experience.
Able and willing to travel up to approximately 25% to AbCellera’s headquarters in Vancouver to collaborate with CMC teammates and colleagues.

Responsibilities

Lead 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.
Lead or contribute to the development of responses to health authority queries.
Provide strategic CMC regulatory guidance and critically review technical documentation, including validation protocols and reports, to ensure strategies and supporting data are scientifically sound and compliant with global regulatory expectations.
Manage critical CMC regulatory timelines and deliverables, partnering with Manufacturing, Quality, and Analytical Development teams to support development and registration objectives.
Maintain detailed knowledge of the global regulatory environment relevant to biologics, communicate changing agency requirements, and support relevant regulatory intelligence as needed by programs.
Identify CMC regulatory program risks, assess their potential impact on development programs, and establish mitigation strategies.
Assess CMC change controls for regulatory impact and ensure ongoing compliance with global regulatory filings.
Partner with CMC, Discovery, Quality, and Clinical Development teams to develop strategies that accelerate submission timelines and contribute as a key project team member.