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

MSD•Kirkland, QC

5d•Hybrid

About The Position

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.

Requirements

Bachelor's degree or higher in Health Sciences or equivalent
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.
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
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

Nice To Haves

Ability to create Access Databases is an asset.

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.
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.