Job Description
Directeur(trice) associé(e) de la conformité, Affaires réglementaires
Le/la Directeur(trice) associé(e) de la conformité, Affaires réglementaires est responsable de la direction de la stratégie de conformité et de sa mise en œuvre pour l’organisation des affaires réglementaires (RA), conformément au Règlement sur les aliments et drogues et aux procédures globales. Il/elle coordonne et dirige le Conseil de conformité Affaires réglementaires, agit comme représentant(e) des politiques approuvées finales et assure la supervision de la création des processus et des bases de données, du suivi de la conformité, ainsi que de la révision annuelle des CV et des descriptions de poste.
Le/la titulaire est également responsable de l’attribution et du suivi des formations, de la mise à jour et du suivi des documents de procédures locales ainsi que des autres exigences liées à la conformité en affaires réglementaires (par exemple : engagements, demandes de sécurité, problèmes de conformité).
Le/la Directeur(trice) associé(e) de la conformité, Affaires réglementaires représente l’organisation des affaires réglementaires au Conseil régional de conformité et, au besoin, au Conseil global de conformité. Il/elle peut également entreprendre d’autres activités supplémentaires, notamment des projets et la direction d’initiatives d’équipe.
Activités et responsabilités principales
Principal point de contact avec Santé Canada et expert(e) métier (SME) responsable des procédures opératoires normalisées (SOP) du Programme d’accès spécial et de leurs références. Collaboration avec les Affaires médicales pour la mise en place de programmes PLPA (accès des patients avant l’autorisation de mise en marché) et/ou UPS (approvisionnement de produits non enregistrés).
Responsable SME des activités locales de surveillance de la conformité ER.
Représentant(e) FEP : réception et évaluation des demandes FEP quant à leur impact réglementaire, y compris sur les processus et procédures.
Coordonne et dirige le Conseil de conformité des affaires réglementaires.
Supervise les mises à jour des documents de procédures par les experts métiers afin d’assurer qu’ils sont à jour, conformes et archivés dans les dépôts officiels.
En tant que responsable des formations 'MyLearning', attribue les formations requises pour la division Recherche et Développement, Affaires réglementaires mondiales, Affaires réglementaires canadienne et autres formations pertinentes. Génère régulièrement des rapports pour analyser les tendances de conformité et adapte les programmes de formation en conséquence.
Assure la supervision de la conformité en cas de non‑conformité (niveaux 1, 2 et 3).
Principal point de contact du département affaires réglementaires et responsable de la supervision des audits et inspections Good Clinical Practices, Good Manufacturing Practices et pharmacovigilance.
Fournit des conseils et un soutien en matière de conformité pour les activités d’affaires réglementaires.
Identifie les besoins et développe les documents de procédures nécessaires afin d’assurer la conformité des activités des affaires réglementaires.
Identifie les besoins de révision des documents de procédures existants.
Réalise toutes les tâches conformément au Code de conduite, aux valeurs et aux normes de l’entreprise, ainsi qu’aux politiques, procédures, normes de l’industrie et aux lois et réglementations. Inclut l’obligation de signaler tous les EI (événements indésirables) et PQC (plaintes qualité produits) selon la politique « Know to Report », la formation en pharmacovigilance et les exigences de Santé Canada.
Autres activités
Gestion de tous les contrats du département des affaires réglementaires conformément aux procédures et exigences locales (moins de 5 % du temps).
Réalisation d’autres activités à la demande du Directeur exécutif, Affaires réglementaires et/ou du Conseil de conformité des Affaires réglementaires.
Qualifications:
Compétences:
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:
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:
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Bachelor's degree or higher in Health Sciences or equivalent
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The incumbent should have a minimum of 5 years’ experience and demonstrated success in Regulatory Affairs and/or Compliance.
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Knowledge of pharmaceutical compliance activities required.
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Strong skill in working with complex systems and databases.
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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:
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Awareness of Health Canada Food and Drug Act and Regulations and ability to interpret
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Knowledge of Regulatory Affairs science, concepts, and terminology
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Knowledge of the local operating procedures
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Understanding of company Global Regulatory Affairs organization, processes, and compliance expectations
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High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents
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Language: French (written and oral)
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Ability to communicate effectively verbally and in writing
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Knowledge of Good Documentation Practices
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Excellent word processing, presentation and spreadsheet application skills
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Familiar with the use of a large project management databases
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Ability to learn new computer interface systems
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Excellent time management, organizational and planning skills
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High level of accuracy and quality in work
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Good collaboration skills
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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.
Requisition ID:R399006
