Regulatory Strategy Manager (Canada)

Vertex Inc.•Toronto, ON

7d•Hybrid

About The Position

The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of Canadian regulatory strategies for development and commercialization of products within the portfolio. This role requires a strong understanding of Canadian regulatory requirements, excellent communication skills, and the ability to collaborate cross-functionally to achieve business objectives.

Requirements

Strong knowledge of Canadian regulatory requirements, including Health Canada regulations, guidelines and submission processes.
Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
Understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines
Strong problem-solving skills
Strong written and verbal communication skills to exchange complex information with others in complex situations
Ability to work effectively within a team environment
Bachelor's degree in Biology, Chemistry, or other related discipline
Minimum 3 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on Canada

Responsibilities

Contributes to the development and implementation of regulatory strategy as a member of the Canadian regulatory affairs team within the Global Regulatory Affairs organization
Responsible for regulatory communications with Health Canada; under supervision, may lead regulatory interactions with the health authority
Review and approve promotional and non-promotional items, including training material, in accordance with local regulatory requirements
Identifies regulatory requirements for development and approval pathways for Canada
Manages the process for preparation, submission, and approval of regulatory applications to Health Canada
Provides technical regulatory input for key product development or registration documents
Provides regulatory guidance and support to cross-functional teams to ensure regulatory compliance throughout the product lifecycle
Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in Canada