Key Responsibilities Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area
Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets
Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs
For Oncology: Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling and resolve product related issues impacting submissions, or compliance activities
For CMC: Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling and resolve product related issues impacting submissions, or compliance activities
Communicates with and influences multiple local and global functions, to achieve regulatory objectives
Identifies and responds to issues related to assigned projects and/or products
Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities
Mentors junior staff
Why you? We are looking for professionals with these required skills to achieve our goals:
B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
For Oncology: Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
For CMC: Extensive Canadian CMC Regulatory experience leading multiple submissions at all stages of the product lifecycle. Experience with small molecules, vaccines, and other biologics is an asset.
Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
Must possess a thorough understanding of drug development and commercialization process
Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
Agile and able to effectively navigate change
Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives
Working knowledge of global regulatory agencies and their practices
Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
Good influencing and relationship management skills
Excellent negotiation skills
Fully developed project management skills




Must act with integrity and demonstrate a strong and effective risk management perspective
Ability to provide and receive feedback, raise issues, share experiences and lessons learned.
Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset.
Open to diverse ideas, styles and perspectives.
Strong commitment to quality mindset
Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
Preferred Qualifications Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
Working Model This role is based in Canada and is hybrid. You will combine in office collaboration with adaptable remote work.
Skills Business Resilience
Communication
Digital Fluency
Matrix Leadership
Pharmaceutical Regulatory Compliance
Stakeholder Management
Salary / compensation 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.
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 [email protected].
GSK uses artificial intelligence (AI) tools as part of the recruitment process to assist in screening and assessing applicants. Final hiring decisions are made by hiring managers, with support from recruiters.
Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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📌 Regulatory Affairs Manager (CMC and/or Oncology) (Ontario)
🏢 GlaxoSmithKline
📍 Ontario