Manager, Regulatory Affairs, Oncology

Manager, Regulatory Affairs, Oncology Are you ready to make a meaningful impact in the world of healthcare? As a Manager, Regulatory Affairs, Oncology, you will play a key role in shaping regulatory strategies and ensuring compliance to bring innovative products to market. Collaborating with cross‑functional teams, you’ll lead submissions, navigate regulatory requirements, and build strong relationships with Health Canada. This role offers opportunities for growth, leadership, and contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together. Responsibilities Develop regulatory strategies accelerated approvals with optimal labelling for products within therapy or for submissions within specialization area Accountable for a portfolio of products, specific in the Oncology therapy area, 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 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 effectively with and influences multiple key 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 and trains junior staff Basic Qualifications B.Sc. in life science or relevant scientific field (e.g., pharmacology, medical oncology, toxicology, chemistry) Extensive Canadian regulatory affairs experience (3 to 5 years of Oncology regulatory experience preferred) leading multiple submissions at all stages of the product lifecycle Experience with solid tumor and/or ADC targeted cancer therapeutics regulatory reviews Experience with Health Canada reviews under NOC/c, and/or priority review accelerated pathways Experience with small molecule and biologics regulatory reviews 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 in life sciences Post‑Graduate Certificate in Regulatory Affairs This role is hybrid, offering a mix of on‑site and remote work in our Mississauga office. Ready to take the next step in your career? Apply today and join us in making a difference #LI-GSK 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, contact us at Please do not send resumes to this e‑mail and instead apply through the online application process of this posting. #J-18808-Ljbffr