Are you a curious, collaborative scientific professional who wants to build trusted relationships with oncology clinicians and help improve patient care across Canada?

Key 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 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?

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)
• 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:
If you have the following characteristics, it would be a plus:

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

Working Model

This role is based in Canada and is hybrid. You will combine on-site collaboration with flexible remote work.

Ready to apply?
We welcome applications from people who bring scientific curiosity, collaboration and a patient-centered mindset. If this role aligns with your experience and purpose, please apply now. We look forward to learning how you can help get ahead of disease together.

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.

This advertisement relates to a current vacancy.

Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Stakeholder Management

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.