Regulatory Affairs Specialist

1 week ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
About GSK

GSK is a global biopharma company that unites science, technology and talent to get ahead of disease together. Our purpose is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

Job Description

We are seeking an experienced Regulatory Affairs Associate to join our team at 837 GlaxoSmithKline Inc. in [location]. This role will be responsible for developing regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area.

Key Accountabilities/Responsibilities
  • Developing Regulatory Strategies: Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area.
  • Portfolio Management: Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets.
  • Compliance and Governance: Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs.
  • Relationship Building: 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.
  • Cross-Functional Collaboration: Communicates with and influences multiple local and global functions to achieve regulatory objectives.
  • Issue Resolution:
  • Regulatory Interpretation: Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities.
  • Mentorship: Mentors junior staff.
Qualifications Required
  • Education: B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
  • Experience: Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
  • Knowledge: Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
  • Commercial Awareness: Must possess a thorough understanding of drug development and commercialization process
  • Innovation and Problem-Solving: 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
  • Agility: Agile and able to effectively navigate change
  • Strategic Thinking: Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives
  • Global Knowledge: Working knowledge of global regulatory agencies and their practices
  • Communication Skills: Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
  • Relationship Management: Good influencing and relationship management skills
  • Negotiation Skills: Excellent negotiation skills
  • Project Management: Fully developed project management skills
  • Risk Management: Must act with integrity and demonstrate a strong and effective risk management perspective
  • Collaboration and Feedback: Ability to provide and receive feedback, raise issues, share experiences and lessons learned
  • Continuous Learning: Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
  • Teamwork: Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives
  • Quality Mindset: Strong commitment to quality mindset
  • Technical Skills: Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
  • Canadian CMC Regulatory Experience: Canadian CMC Regulatory experience with small molecules, vaccines, and other biologics is an asset
Preferred Qualifications
  • Graduate Degree: Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
Compensation and Benefits

The estimated salary range for this position is between $80,000 to $120,000 per year, depending on experience. In addition to a competitive salary, we offer a comprehensive benefits package, including medical, dental, vision, and disability insurance, as well as a generous retirement plan.

Why Join Us?

At GSK, we are passionate about improving the lives of patients around the world. As a member of our team, you will have the opportunity to work with a talented group of professionals who share your passion for innovation and excellence. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.

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