Description
We are seeking a Regulatory Affairs Specialist to join our team in Canada. As a Regulatory Affairs Specialist, you will lead key activities to progress your career, including developing regulatory strategies for rapid approvals, preparing and filing regulatory submissions, and ensuring compliance with Health Canada guidelines.
Key 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, 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
Basic Qualifications:
- 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
Preferred Qualifications:
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
Working Model: This role is based in Canada and is hybrid. You will combine on-site collaboration with flexible remote work.
Salary: The annual compensation for this role is CAD 111,000 to CAD 161,000, determined based on experience, qualifications, and internal equity.