Regulatory Affairs Manager (CMC and/or Oncology)

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

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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

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)

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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

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.