Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to join our team in Mississauga, Ontario. As a Regulatory Affairs Specialist, you will provide input into the planning of submissions/activities, assist in the preparation of regulatory submissions/activities, ensure regulatory compliance with Health Canada, industry, and GSK codes and guidelines, and interpret Canadian regulations, guidelines, and policies.

Responsibilities:

• Provide input into the planning of submissions/activities
• Assist in the preparation of regulatory submissions/activities (e.g., NDSs, SNDSs, CTAs, NCs, Training, Compliance)
• Ensure regulatory compliance with Health Canada, industry, and GSK codes and guidelines
• Assist in the preparation of internal reports or responses to Health Canada requests
• Establish contact and communicate with global and local teams on project-related plans and issues
• Identify and respond to issues related to assigned projects, resolve basic regulatory questions
• Communicate with and may build relationships with Health Canada
• Interpret Canadian regulations, guidelines, and policies as they apply to GSK regulatory activities
• Experience working with Veeva Vault

Requirements:

• B.Sc. in life science or relevant scientific field (e.g., pharmacology, toxicology, chemistry)
• Some experience in regulatory affairs
• Understanding of the Canadian Food and Drug Regulations, relevant guidelines, and policies
• Knowledge of regulatory requirements and processes for all types of submissions
• Basic understanding of drug development and commercialization process
• Agile with the ability to react quickly, provide creative solutions to problems, and navigate change
• Good oral and written communication skills
• Demonstrated negotiation skills
• Accountable to simultaneously work on multiple projects and meet tight timelines
• Excellent attention to detail and accuracy of work
• Acts with integrity and demonstrates a strong quality mindset
• Ability to provide and receive feedback, raise issues, share experiences, and lessons learned
• Proactive and seeks to constantly learn and develop
• Collaborative with the ability to work with diverse groups of individuals in a team
• Competence with electronic business environment and computer skills including Word, Excel, PowerPoint, Outlook

Preferred Qualifications:

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

What We Offer:

• Annual compensation: CAD 82,000 to CAD 132,000, determined based on experience, qualifications, and internal equity
• Hybrid work model combining on-site collaboration with flexible remote work