Site Name: Mississauga Milverton Drive Posted Date: Jan 31 2025 At GSK, the Manager, Regulatory Affairs Oncology, is responsible for the development and implementation of regulatory strategic plans, leading submissions and negotiations with Health Canada to achieve product approvals while optimizing and meeting business objectives. The ideal candidate will have at least 3 to 5 years' experience in oncology, specifically scientific knowledge of antibody-drug conjugates, anti-PD-1 antibodies, and/or anti-TIM-3 monoclonal antibodies. It will also be important to have solid experience collaborating with local and global cross-functional teams, have a growth mindset and the ability to thrive in a fast-paced environment. Underpinning these key responsibilities is a strong culture of compliance to GSK Company values, relevant policies, procedures and ethical practices What you will do: 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, 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 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 and trains junior staff Why you? Basic Qualifications: 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, biology) 5 years of oncology regulatory affairs experience Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle 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 Preferred Qualifications: If you have the following characteristics, it would be a plus: Graduate degree and/or post graduate certificate in medical oncology Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. #LI-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. 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. GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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. 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. 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