About The Position
The Associate Director, Regulatory Affairs Compliance is responsible for leading the compliance strategy and execution for the RA organization in accordance with the Food and Drug Regulations and Global procedures. This role coordinates and leads the Regulatory Affairs Compliance Council, serves as the Final Executed Policy (FEP) representative, and provides oversight for the creation of processes and databases, compliance reporting, and the annual review of CVs and job descriptions. The position is also responsible for the assignment and tracking of training, updating and tracking local procedural documents, and managing other compliance-related requirements such as commitments, safety requests, and compliance issues. The Associate Director will represent the RA organization at the Regional Compliance Council and, as needed, at the Global Compliance Council. Additional activities may include projects and leadership of team initiatives.
Requirements
- Bachelor's degree or higher in Health Sciences or equivalent.
- Minimum of 5 years of experience and demonstrated success in Regulatory Affairs and/or Compliance.
- Knowledge of pharmaceutical compliance activities.
- Strong skill in working with complex systems and databases.
- Ability to create Access Databases is an asset.
- Strong communication and time management skills.
- 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) language proficiency.
- 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 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.
Responsibilities
- Primary Health Canada contact and Subject Matter Expert (SME) for the Special Access Program Standard Operating Procedure (SOP) and its references.
- Collaborate with Medical Affairs for the establishment of PLPA (Pre License Patient Access) and/or Unregistered Product Supply programs.
- SME for local compliance monitoring activities.
- FEP representative, receiving and assessing FEP requests for regulatory impact on processes and procedures.
- Coordinate and lead the Regulatory Affairs Compliance Council.
- Oversee updates of procedural documents by SMEs to ensure they are current, compliant, and archived in official repositories.
- As MyLearning steward, assign required training for the Research and Development Division, Global Regulatory Affairs, Canada Regulatory Affairs, and other pertinent training.
- Periodically run reports from MyLearning to track compliance trends, evaluate trends, and adjust training curricula.
- Ensure compliance oversight for 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.
- Provide compliance guidance and support on Regulatory Affairs activities.
- Identify needs and develop relevant procedural documents to ensure compliance of Regulatory Affairs activities.
- Identify the need for revision of existing procedural documents.
- Complete all tasks in accordance with the Company’s Code of Conduct, Our Values and Standards, policies, procedures, industry standards, and all laws and regulations, including reporting Adverse Events and Product Quality Complaints.
- Manage all contracts for the RA department in accordance with local procedures and requirements (less than 5% of time).
- Perform other activities as requested by the Executive Director, Regulatory Affairs and/or RA Compliance Council.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
