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Regulatory Affairs Specialist

1 month ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Key Accountabilities/Responsibilities:
  • 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.
  • Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling 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 regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
  • 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
  • Canadian CMC Regulatory experience with small molecules, vaccines, and other biologics is an asset
Preferred Qualifications
  • Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.