Regulatory Affairs Manager, CMC

Site Name: Mississauga Milverton DrivePosted Date: Jan 14 2026 Position Summary You will lead regulatory CMC (Chemistry, Manufacturing and Controls) activities in Canada to support product development and lifecycle maintenance. You will work with cross‑functional teams including R&D, Quality, Manufacturing and Commercial to build clear regulatory strategies and prepare submissions. We value people who are collaborative, curious and focused on practical solutions. You will grow your skills, influence outcomes that matter to patients and help GSK unite science, technology and talent to get ahead of disease together.

Responsibilities

Develop and execute CMC regulatory strategies for product development and lifecycle activities in Canada. Prepare, review and submit CMC sections for regulatory filings, including initial submissions, variations, supplements and periodic updates. Coordinate cross‑functional input to ensure submission readiness and timely responses to regulator questions. Engage with Health Canada and other regulatory stakeholders to negotiate outcomes and resolve CMC issues.

Drive process improvements to reduce cycle time and improve the quality of regulatory deliverables. Mentor junior colleagues and share best‑practice approaches across teams. Why You? We are seeking professionals with the following required skills and qualifications to help us achieve our goals.

Basic Qualification Bachelor’s degree in a relevant scientific discipline such as chemistry, pharmaceutical sciences, biochemistry or engineering. At least 3 years’ experience in CMC‑focused regulatory affairs or equivalent role supporting submissions in Canada. Demonstrated knowledge of Canadian regulatory requirements for pharmaceuticals, biologics or related products.

Experience

with biologics, cell and gene therapies, or complex modalities.

Experience

preparing or managing CMC documentation for regulatory submissions.

Experience

with Health Canada review pathways, accelerated review or lifecycle maintenance. Strong written and verbal communication skills for clear technical writing and stakeholder engagement. Proven ability to drive results, proactively anticipate and manage risks, konstrukti feedback. Proven ability to work collaboratively with cross‑functional teams and manage competing priorities.

Preferred Qualification Advanced degree (MSc, PharmD, PhD) or postgraduate qualification in regulatory affairs. Familiarity with global CMC regulations and ICH guidance.

Experience

applying lean or continuous improvement methods to regulatory processes. Prior experience mentoring or leading small regulatory teams. Location and Working Model This role is based in Canada. The position is hybrid, combining on‑site collaboration with flexible remote work.

How to Apply

If this role fits your skills and ambitions, we encourage you to apply. Join us and help shape regulatory approaches that deliver meaningful impact for patients. We welcome applicants from all backgrounds and are committed to an inclusive workplace where people can grow and contribute.

Salary

Range In compliance with Ontario’s provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD 111 sebelisa 000 to CAD 161,000, determined based on experience, qualifications, and internal equity. Equal Opportunity Statement GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada‑recruitment@gsk.com. Please do not send resumes to this e‑mail and instead apply through the online application process of this posting. #J-18808-Ljbffr