Associate Director Regulatory Affairs

About Knight

Knight Therapeutics is a pan-American (ex-US) specialty pharmaceutical company focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. Knight Therapeutics shares trade on TSX under the symbol GUD. Headquartered in Montreal, Knight has nearly 700 employees globally.

We are seeking a Regulatory Affairs Associate Director to lead our Canadian Regulatory Affairs department and collaborate with our corporate partners to ensure timely approval and regulatory compliance of pharmaceutical products in Canada. This position will offer an exciting opportunity to lead regulatory strategies, manage a talented team, and contribute to our company's success in a dynamic and challenging environment.

This position reports to the Global Regulatory Affairs Director.

We have recently signed very exciting projects involving participation from various countries, including those in Latin America.

If you have experience in pharmaceutical regulation, excellent communication and leadership skills, and are ready to tackle exciting challenges, apply now to join our team!

Specific Responsibilities

1. Develop and implement regulatory strategies aligned with business objectives to support the registration, approval, and commercialization of pharmaceutical products in Canada.
2. Oversee the preparation, review, and submission of regulatory documents, including pre-submission meetings, new drug applications (NDAs), supplemental applications, variations, and annual reports, ensuring accuracy, completeness, and compliance with regulatory requirements.
3. Build regulatory timelines to support the company business plans. Develop strategic goals with staff, and provide guidance as needed for completion of tasks. Maintain effective communication with partners and project team members. Report progress, challenges, issues, actions and support required.
4. Manage regulatory aspects of the product portfolio throughout its lifecycle, including post-marketing activities such as variations and label updates.
5. Collaborate with other departments to develop internal processes in Regulatory Affairs.
6. Liaise with Health Canada and represent the company in regulatory meetings.
7. Lead and mentor a team of regulatory professionals, providing training and ongoing support.
8. Stay informed about industry trends and emerging regulatory requirements, providing strategic advice to senior management..
9. Contribute to the development of business strategies considering the regulatory environment.
10. Identify regulatory risks and opportunities, assess potential impact, and develop risk mitigation strategies.
11. Effectively communicate regulatory requirements within the organization.

Characteristics of the Ideal Candidate

• Analytical and Organizational Skills: Attention to detail and commitment to accuracy.
• Negotiation and Teamwork Skills: Ability to communicate effectively with diverse groups.
• Ability to Multitask: Capacity to work in a dynamic environment and handle multiple projects simultaneously.
• Autonomy and Problem-Solving: Ability to work independently and resolve issues in a timely manner.
• Adaptability: Ability to adapt to constant changes and evaluate documents according to Canadian regulatory requirements.

Candidate Profile

Education

Required

• Advanced scientific degree (i.e. MSc, PharmD, PhD, MD) or

MD, PharmD, PhD, MS in life science /or an equivalent combination of education or experience

Experience

• Strong scientific knowledge
• Strong knowledge of the Canadian regulations and good ability to interpret policies and guidelines.
• Excellent communication skills, written and oral in English and French

Assets

• M.Sc. in drug development
• 5 years within the pharmaceutical industry, including managerial responsibilities.
• Knowledge of international regulations
• Spanish or Portuguese (written and oral)

Other

• Good knowledge of Microsoft Office Suite
• Project management tools

As illustrated in the description of the tasks, it requires, in particular, to communicate, verbally and in writing, with the other team members located across Canada as well as Latin America as well as customers across Canada. Following an assessment, we have therefore determined that the performance of these tasks requires the knowledge of the English language, in addition to the knowledge of the French language (written and spoken). We have also determined that the English knowledge already required from other employees is insufficient for the performance of the duties requiring the knowledge of English

Please send your CV and cover letter to careers@knighttx.com

Only selected candidates will be contacted.