Directeur(trice) associé(e), Conformité des affaires réglementaires /Associate Director, Compliance Regulatory Affairs

Job Description

Required Skills:

Adaptability, Change Management, Communication, Compliance Oversight, Cross-Cultural Awareness, Data Management, Employee Training Programs, Leadership, Project Management Information Systems (PMIS), Regulatory Affairs Compliance, Regulatory Operations, Strategic Thinking, Systems Development Lifecycle (SDLC), Working Independently

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

The Compliance Associate Director, Regulatory Affairs is responsible for leading the compliance strategy and execution for the RA organization in accordance with the Food and Drug Regulations and Global procedures. Compliance Associate Director, Regulatory Affairs coordinates and leads the Regulatory Affairs Compliance Council, is the Final Executed Policy (FEP) representative, and provides oversight over the creation of processes/databases, compliance reporting, annual review of CVs and job descriptions.

The Compliance Associate Director, Regulatory Affairs is responsible for assignment and tracking of trainings; tracking and updates to local procedural documents as well as other compliance related tracking requirements (i.e., Commitments, Safety Requests, Compliance Issues). The Compliance Associate Director, Regulatory Affairs will represent the RA organization at the Regional Compliance Council and, on an ad hoc basis, at the Global Compliance Council. The Compliance Associate Director, Regulatory Affairs may undertake other additional activities including projects and leadership of team initiatives.

Major Activities and Responsibilities

• Primary Health Canada contact and Subject Matter Expert owner of the Special Access Program Standard Operating Procedure and Standard Operating Procedure references. Collaboration with Medical Affairs for the establishment of PLPA (Pre License Patient Access) and/or Unregistered Product Supply) programs.

• Subject Matter Expert owner of the Local Compliance Monitoring Activities.

• FEP representative. Receiving and assessing FEP requests for regulatory impact, including impact on processes and procedures.

• Coordinates and leads the Regulatory Affairs Compliance Council.

• Oversees updates of procedural documents by Subject Matter Experts to ensure all procedural documents are maintained up-to-date and compliant and are archived in the official repositories.

• As MyLearning steward, assigns the required Research and Development Division, Global Regulatory Affairs, Canada Regulatory Affairs and other pertinent training items. Periodically runs reports from MyLearning to track compliance trends. Evaluates trends and adjusts training curricula to meet current compliance requirements.

• Ensures compliance oversight over non-compliance issues (Level 1, 2 and 3).

• Regulatory Affairs Department primary contact and lead for oversight of Good Clinical Practice, Good Manufacturing Practice and Pharmacovigilance audits and inspections.

• Provides compliance guidance and support on Regulatory Affairs activities.

• Identifies the need and develops relevant procedural documents to ensure that all Regulatory Affairs activities adhere to compliance requirements.

• Identifies the need for revision of existing procedural documents.

• The incumbent will complete their tasks in a manner 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. This includes the obligation to report all Adverse Events and Product Quality Complaints as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada regulations.

Other Activities

• Management of all contracts for the RA department in accordance with local procedures and requirements. Activities should be less than 5% of time.

• Perform other activities as requested by the Executive Director, Regulatory Affairs and/or RA Compliance Council.

Requirements:

• Bachelor's degree or higher in Health Sciences or equivalent
• The incumbent should have a minimum of 5 years’ experience and demonstrated success in Regulatory Affairs and/or Compliance.
• Knowledge of pharmaceutical compliance activities required.
• Strong skill in working with complex systems and databases.
• Ability to create Access Databases is an asset. The individual is expected to have strong communication and time management skills and the ability to work independently with minimal supervision.
   

Competencies:

• Awareness of Health Canada Food and Drug Act and Regulations and ability to interpret
• Knowledge of Regulatory Affairs science, concepts, and terminology
• Knowledge of the local operating procedures
• Understanding of company Global Regulatory Affairs organization, processes, and compliance expectations
• High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents
• Language: French (written and oral)
• Ability to communicate effectively verbally and in writing
• Knowledge of Good Documentation Practices
• Excellent word processing, presentation and spreadsheet application skills
• Familiar with the use of a large project management databases
• Ability to learn new computer interface systems
• Excellent time management, organizational and planning skills
• High level of accuracy and quality in work
• Good collaboration skills
• Compliance mindset/focused

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

06/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.