Senior Regulatory Affairs Consultant

About the role

ProductLife Group is seeking an experienced Senior Regulatory Affairs Consultant to act as a senior regulatory advisor and lead complex client engagements across biotechnology, pharmaceutical and medical device programs. The role will support development programs from pre‑IND and early development through registration and marketing approval.

Key responsibilities

• Serve as Regulatory Lead for client engagements, developing and executing regulatory strategies aligned with development objectives and submission plans.
• Lead multidisciplinary regulatory projects, defining workplans, timelines, budgets, resource requirements and delivery approaches.
• Coordinate, author and review regulatory documents such as health‑authority meeting packages, special designation requests, INDs, NDAs, BLAs, CTAs, amendments and regulatory correspondence.
• Represent clients in formal interactions with health authorities, develop meeting strategies and coach clients for meetings.
• Interpret and apply FDA, Health Canada, ICH, GxP and other global regulatory guidance and standards.
• Manage cross‑functional teams, monitor project progress, identify risks and develop mitigation plans.
• Contribute regulatory expertise to scoping, proposals, budgeting and business development activities.

Required profile

• Bachelor’s degree in a life‑science or related discipline.
• 10–12 years of progressive regulatory affairs experience in biotechnology, pharmaceuticals, medical devices or life‑science consulting.
• Proven experience developing regulatory strategies from early development through registration.
• Strong ability to lead complex projects and interact with health authorities.

Required skills

• Knowledge of FDA regulations.
• Knowledge of Health Canada regulations.
• Familiarity with ICH guidelines.
• Understanding of GxP requirements.
• Regulatory strategy development.
• Regulatory document preparation and review.