Job Description

Manager, Regulatory Affairs, Oncology
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
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Position Summary
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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Develops 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
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, medical oncology, toxicology, chemistry), see preferred qualifications
• 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
If you have the following characteristics, it would be a plus:

• 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
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 . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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