Regulatory Affairs Associate or Project Leader
GSK
Mississauga, ON
Site Name: Canada - Ontario - Mississauga
Posted Date: Sep 25 2019

Description:
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.

Primary Responsibilities:
  • Provides input into the planning and supports preparation of regulatory submission (NDSs, SNDSs, CTAs, NCs, etc.) to aggressive targets, within a team environment
  • Ensures regulatory compliance with Health Canada requirements and alignment with business needs
  • Provides input into the development of submission strategies and works with others to negotiate with Health Canada towards rapid approval with optimum labeling
  • Liaises with multiple local and global functional groups to ensure Canadian regulatory needs are met
  • Identifies and responds to issues related to assigned projects
  • Interprets Canadian regulations, guidelines and policies as they apply to GSK commercial activities
Required Qualification:
  • B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
  • Minimum 2 years of experience in regulatory affairs, including chemistry and manufacturing, clinical and labeling submissions
  • Good working knowledge of the Canadian Food and Drugs Regulations, relevant policies and guidelines. Working experience with Health Canada is a MUST
  • Good understanding of the drug development and commercialization process
  • Ability to react quickly and provide creative solutions to problems.
  • Excellent oral and written communication with the ability to present to small and large groups
  • Good negotiation skills
  • Excellent attention to detail and accuracy of work
  • Act with integrity and demonstrate a strong commitment to a quality mindset
  • Able to manage multiple projects and tight timelines.
  • Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
  • Ability to work with diverse groups of individuals in a team.
Preferred Qualifications:
  • Graduate degree
  • LI-GSK
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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