Directeur(rice) exécutif(ve), affaires réglementaires Canada / Executive Director, Regulatory Affairs Canada

Merck•Kirkland, QC

2d•Hybrid

About The Position

The Executive Director, Regulatory Affairs leads the Regulatory Affairs department in Canada, which includes Clinical, CMC, Publishing, Labelling and administrative work. The goal is to ensure the success and compliance of all company products. This includes registration of new products (small molecules, biologics, vaccines, companion diagnostics etc.), maintenance of marketed products, registration and maintenance of Clinical Trial Applications, compliance of Drug Safety submissions, compliance with GMP requirements, including the company Drug Establishment License (DEL), IP protection (Health Canada patent list and data protection) and Regulatory Policy. The Executive Director is an active member of the RAI Leadership Team and the Canada Executive Management team. The Executive Director may assume leadership/sponsorship of global projects as required.

Requirements

The incumbent must have a University Degree, M.Sc. or higher in Health Sciences or equivalent.
The individual should have a significant and proven track record of success in multiple aspects of regulatory science (Clinical, CMC, Publishing, Labelling) with at least 15 years of experience in regulatory Affairs including people management experience.
The individual must have excellent communication skills (both written and verbal) and strong leadership characteristics particularly such as Influence, Drive Results, Collaboration and Strategic Mindset.
Expert Level Knowledge of Health Canada Laws, Regulations, Guidance and Policies
Authoritative knowledge and interpretation of Health Canada Food and Drug Act and Regulations
Strong ability to explain Canadian requirements/laws and ensure compliance in groups outside of Regulatory Affairs.
Expert Scientific Knowledge and Ability to Learn New Science/Products
Ability to learn and understand the scientific data supporting new products, new indications and major chemistry and manufacturing aspects for small molecule, biologics and vaccines: Preclinical, Clinical/Statistics, Chemistry, Manufacturing & Companion Diagnostics.
Ability to quickly understand and interpret questions/comments from the Health Authority and provide guidance to global regulatory affairs senior management.
Experience and high-level understanding of key areas of the business, including Supply Chain, Planning, Marketing/Sales, Finance, Legal, Compliance, Drug Safety.
Demonstrated expertise in strategic planning.
Demonstrated expertise in building talent and employee motivation/engagement
Poised crisis management skill
Financial stewardship and budget management
Proficiency in French (both written and spoken) is required. Knowledge of English is required to support interactions with Health Canada and global headquarters.
Excellent presentation skills
Excellent written communication that is clear and concise and easily interpreted.
Excellent word processing, presentation & spreadsheet application skills
Experience with the use of large compliance databases
Experience with the use of artificial intelligence applications
High level of resilience.
Excellent time management, organizational & planning skills
High level of ethics and integrity and ability to make tough decisions to ensure compliance and ethics.
Compliance mindset/focused
Courage and candor

Responsibilities

Develop a department structure and allocate resources that support a high-functioning and compliant Regulatory Affairs organization.
Provide strategic support and guidance for business-critical product-related regulatory projects, business development projects and cross-functional company projects/initiatives. This includes but not limited to: Company Drug Establishment License, New Product Registrations and Major New Indications, Maintenance of Marketed Products, Drug Safety submissions, Clinical Trial Applications among others.
Lead Regulatory Policy and participate actively in Innovative Medicines Canada and/or BIOTECanada driving regulatory policy changes, collaborating closely with Global Regulatory Policy organization.
Oversee and guide Associate Director, Compliance to ensure compliance with all company and Health Canada requirements.
Active member of the company Medical Council.
Collaborate closely with Quality Assurance in the management of product quality issues that could impact supply (including recall) or patient safety.
Collaboration and support of Legal Affairs projects.
Develop staff skill sets for both technical skills and leadership.
Ensure the work is fully consistent with The Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all laws and regulations. The incumbent must report all AEs and PQCs as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada regulations.
Undertake other activities requested by the Vice President, Regulatory Affairs International.