Regulatory Affairs Manager
GSK
Mississauga, ON
Site Name: Canada - Ontario - Mississauga
Posted Date: Aug 19 2019
GSK is a leading pharmaceutical company. GSK’s Regulatory Affairs department is a team of professionals who are dedicated to excellence in all aspects of Regulatory Affairs. We are actively looking for a motivated, creative Regulatory Affairs Professional to join our dynamic team. We welcome applicants with previous experience working in Regulatory Affairs who are looking to gain valuable experience working with GSK.

Basic Qualification:
Develops regulatory strategies for rapid approvals in Canada.
Prepares 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 resolves 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
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)
Minimum 5 years significant experience in Canadian CMC Regulatory leading multiple submissions at all stages of the life cycle, with a focus on vaccines.
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
Experience with small molecules and other biologic is an asset.
Highly innovative (strategic and functional), creative problem solver and decision maker, who can apply continuous improvement techniques to gain efficiencies in submission preparation and product approval process
Working knowledge of global regulatory agencies and their practices
Demonstrated ability to develop and deliver effective and ambitious regulatory strategies aligned with commercial objectives
Fully developed project management skills
Excellent oral and written communication skills with the ability to present to small and large groups
Excellent negotiation skills
Strong commitment to a quality mindset
Ability to engage constructively with others and demonstrate a positive mindset
Must act with integrity and demonstrate a strong and effective risk management perspective
Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook

Preferred Qualifications:
Graduate degree
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. 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

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