Executive Director, Regulatory Affairs

About the Company

Successful bio-pharmaceutical company with a global presence

Industry
Pharmaceuticals

Type
Public Company

Founded
1891

Employees
10,001+

Categories

- Pharmaceuticals

About the Role

The Company is seeking an Executive Director for Regulatory Affairs in Canada. The successful candidate will be responsible for leading the Regulatory Affairs department, which encompasses a wide range of activities including clinical, CMC, publishing, labeling, and administrative work. The primary objective is to ensure the success and compliance of all the company's products, from the registration of current products to the maintenance of marketed products and adherence to all regulatory requirements. The role also involves strategic support for business-critical regulatory projects, leading regulatory policy, and active participation in driving policy changes. The Executive Director will be a key member of the leadership team, with the potential to take on global project leadership as needed.





Applicants must have a University degree, M.Sc. or higher in health sciences, and a minimum of 15 years' experience in regulatory affairs, with a proven track record in various aspects of regulatory science. The role requires excellent communication skills, strong leadership characteristics, and the ability to manage and mentor staff. Functional competencies include expert-level knowledge of Health Canada laws and regulations, as well as the ability to understand and interpret complex scientific and regulatory information. The ideal candidate will have a high level of resilience, a strong ethical and compliance-focused mindset, and the courage to make tough decisions to ensure the company's commitment to ethics and compliance. Proficiency in French is required, with a good command of English for interactions with global headquarters.

Hiring Manager Title
Vice President, Regulatory Affairs International

Functions

- Legal
- Operations

📌 Executive Director, Regulatory Affairs (Kirkland)
🏢 Confidential
📍 Kirkland