Senior Director, Regulatory Affairs

The Senior Director is responsible for providing regulatory direction and management to the Canadian Regulatory Team, for Branded development projects and post-approval regulatory support for the company’s marketed products. This includes guiding staff at all levels on relevant and strategic regulatory advice for global branded development plans to ensure high level of success during registration phase in Canada. The candidate will be part of the Global Regulatory Affairs Brand LeadershipTeam, providing updates on the status of ongoing and planned interactions with Health Canada and participating on Regulatory initiatives to improve best practices.

The candidate will participate in setting and attaining the goals of the organization, overall planning, control, execution and evaluation of the business. As a leader in the Canadian office, the candidate will support the team, act as a change agent within the organization and demonstrate the leadership skills required for the role.

The candidate will create strong and effective relationships with peers including Marketing, Sales, Market Access, and Medical Affairs.

In more details the candidate will:

• Directs the Regulatory Team efforts required for the submission of CTAs, NDSs and sNDSs as well as related supplements/variations and annual reports, as needed 
• Reviews, evaluates and approves all applications and submissions
• Reviews, comments and advises on Promotional Review materials  as part of Copy Approval Committee. Ensures adherence of promotional materials to PAAB standards. Acts as the internal expert in alignment to PAAB and Health Canada requirements 
• Provides regular and timely updates to Sr. regulatory management and management team on the status of all pending applications and planned submissions as necessary.

• M. Sc, PhD or PharmD;
• +10 years experience in pharmaceutical regulatory affairs;
• Strong knowledge of drug development process and Canadian regulations to include clinical and preclinical (Toxicology and DMPK); some CMC knowledge is preferrable;
• At least 5 years of managerial experience in RA
• Demonstrates proficient knowledge of Health Canada guidelines within the pharmaceutical industry
• Demonstrates excellent project and people management skills
• Demonstrates the ability to work with and/or lead a diverse group of individuals at all levels of the organization, both internally and externally.