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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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, give and receive feedback.
- Proven ability to work collaboratively with cross-functional teams and manage competing priorities.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- 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.
#LI-Hybrid
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 CAD111,000 to CAD161,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
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