CMC Regulatory Affairs Manager

GSK - Mississauga, ON (30+ days ago)

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Site Name: Canada - Ontario - Mississauga
Posted Date: Jun 24 2020

GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and health-care companies, is committed to improving the quality of life by enabling people to do more, feel better, and live longer. GSK’s Regulatory Affairs department is a world-class team of professionals who are dedicated to excellence in all aspects of regulatory affairs. We are actively looking for a motivated, bold, decisive, and innovative team player to join and add value to our dynamic team. If you are an energetic, career-minded professional with a passion for leadership, a focus on solutions, and a commitment to outstanding performance, we invite you to apply to our exciting and rewarding role. We welcome applicants with previous experience working in Regulatory Affairs who are looking to gain valuable experience working with one of Canada’s best employers.

Primary Responsibilities:
Develops regulatory strategies for rapid approvals of 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
Builds trust with Health Canada contacts to improve GSK submission approval times, and resolve product related issues impacting submissions, supply continuity 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

Qualifications Required:
B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
Extensive Canadian CMC regulatory affairs 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:
Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

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GSK is an equal opportunity employer committed to diversity and inclusion. We welcome 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 Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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