Director, Regulatory Affairs (Regulatory Strategy)
Core
Develop and implement regulatory strategies for drugs, biologics, and combination products for current and prospective clients in Canada.
Role type
Senior IC regulatory strategy director
Builds
Regulatory submissions (NDS/SNDS, CTA), strategic advice, and client project plans
Domain
Healthcare / Canadian Regulatory Affairs
Deliverable
client delivery
Required skills
Canadian regulatory strategy, Health Canada interactions, small molecules, biologics, gene therapy, cell therapies, regulatory writing, dossier preparation, accelerated pathways, people management, business development
Preferred skills
Rare disease experience, post-market support experience
Technologies
NDS, SNDS, CTA
Responsibilities
Anticipate and implement regulatory strategies for clients; Act as scientific thought leader; Provide strategic advice on regulatory queries; Manage workflow and client contracts; Train and coach team members; Oversee preparation of Health Canada submissions (Module 2); Function as primary liaison with Health Canada; Support business development and proposal writing.
