Regulatory Affairs Consultant - Lifecycle Management

Regulatory Affairs Consultant - Lifecycle Management

We are seeking an experienced Regulatory Affairs professional with Canadian regulatory expertise to provide embedded support for the lifecycle management of five products currently marketed in Canada.

This is an opportunity to work closely with the client’s regulatory organisation, providing hands‑on support across routine regulatory submissions, complex regulatory activities, submission management and Health Authority interactions.

• Provide embedded Canadian Regulatory Affairs support across five marketed products.
• Lead the development and management of regulatory submissions, including routine submissions and supplements, as agreed with the client.
• Develop and execute regulatory strategies for complex submissions, ensuring appropriate regulatory pathways and approaches are identified.
• Act as the primary liaison with the Canadian Health Authority, coordinating interactions and supporting responses and follow-up activities.
• Manage submission activities throughout the regulatory lifecycle, including planning, coordination, review and delivery.
• Collaborate closely with the client’s dedicated RA CMC group, which is responsible for the CMC components of submissions.
• Coordinate cross-functional input and ensure regulatory deliverables are aligned, complete and submitted according to agreed timelines.
• Provide ongoing regulatory advice and support for the five products throughout their life-cycle management.

Over the next 12 months, the portfolio is anticipated to include approximately:

• 6-8 CMC supplements

The client has a dedicated RA CMC group responsible for the CMC submissions and associated activities.

• Strong experience in Canadian Regulatory Affairs, ideally supporting marketed pharmaceutical products and life-cycle management.
• Demonstrated experience developing and managing regulatory submissions and supplements.
• Experience developing regulatory strategy for complex submissions.
• Proven ability to manage Health Authority interactions and act as a primary regulatory liaison.
• Strong project management and stakeholder coordination skills.
• Ability to work effectively as an embedded regulatory resource within an established client team.
• Experience collaborating with dedicated CMC regulatory teams is highly desirable.
• Excellent communication, organisational and problem-solving skills.

Commitment: 35-40 hours per week

Focus:
Canadian Regulatory Affairs / Life-Cycle Management

Portfolio:
Five products currently marketed in Canada

If you are an experienced Canadian Regulatory Affairs professional looking for an embedded consultancy assignment with significant submission and Health Authority engagement, we would be interested in hearing from you.