The posting
POSITION SUMMARY The Senior Specialist is responsible for ensuring that all pharmacy operations adhere to applicable Canadian laws, regulations, and industry standards. This role involves overseeing compliance with federal and provincial regulations governing the practice of pharmacy while leading the development and implementation of standardized pharmacy operating processes and models that support patient safety, operational integrity, and ethical standards. The Senior Specialist will work closely with cross-functional teams to embed regulatory requirements into practical and efficient workflows; manage audits; developing policies, and provide guidance on regulatory and process standards to ensure consistent execution across the network. RESPONSIBILITIES Regulatory Compliance:
Ensure all pharmacy operations comply with Canadian federal and provincial regulatory requirements (e.g., the Controlled Drugs and Substances Act, Food and Drugs Act, Narcotic Control Regulations, and provincial pharmacy laws). Stay up-to-date on changes to pharmacy-related legislation, regulations, and policies, and communicate changes to relevant stakeholders Monitor compliance with the Canadian Anti-Spam Legislation (CASL), Health Canada regulations, and provincial health authority guidelines.
Process & Workflow Standardization:
Lead the design, standardization of pharmacy processes and workflows to enable a scalable, consistent, and high-performing operating model across the network Ensure processes translate enterprise priorities into practical, field-ready execution that balances quality, compliance, efficiency, and patient experience. Establish and sustain enterprise process standards, frameworks, and tools that enable consistent execution while allowing for appropriate local application. Partner cross-functionally with Operations, IT, Pharmacy Excellence and Finance to translate regulatory requirements and strategic priorities into integrated, pharmacy end-to-end workflows. Identify variation, inefficiencies, and root causes across workflows; lead the development of improvement opportunities that enhance productivity, quality, and user experience. Leverage data, field feedback, and performance insights to monitor effectiveness and inform continuous improvement and optimization efforts.
Policy and Procedure Development:
Develop, implement, and regularly update pharmacy compliance policies and procedures in line with evolving regulatory standards. Ensure internal processes align with legal and ethical standards governing drug handling, storage, and dispensing. Review and improve standard operating procedures (SOPs) related to drug safety, inventory control, patient privacy (HIPAA), and drug disposal.
Risk Management and Auditing:
Conduct regular compliance audits across pharmacy operations to assess adherence to regulatory standards. Identify and address areas of non-compliance or potential risks to patient safety, security, and legal obligations. Support the development and execution of corrective action plans in response to audit findings or regulatory violations. Report compliance issues and violations to senior management, regulatory bodies, and other stakeholders as required.
Training and Education:
Lead training sessions and workshops to educate pharmacy staff on relevant regulatory requirements and compliance best practices. Ensure continuous professional development programs are in place to promote awareness of changing legislation and compliance obligations. Provide guidance and resources to pharmacy staff regarding regulatory interpretation and best practices.
Investigations and Reporting:
Investigate any potential breaches in compliance, including incidents involving the improper handling of medications, fraudulent activities, or violations of patient confidentiality. Work with relevant departments (e.g., legal, risk management) to ensure investigations are thorough and appropriate actions are taken. Prepare reports and documentation for regulatory agencies, internal stakeholders, or as part of audit requirements.
Analyze medication incident and privacy breach data, report insights to Senior Leadership, and publish quarterly safety and medication‑safety communications to support continuous improvement.
Relationship Management:
Act as the primary point of contact for external regulatory agencies (Health Canada, provincial regulatory bodies, etc.) regarding compliance matters. Collaborate with senior leadership to ensure the pharmacy’s compliance program aligns with broader organizational goals. Serve as a resource for pharmacy field operations, pharmacy staff and management to resolve compliance-related questions or concerns.
QUALIFICATIONS & SKILLS Education & Experience:
Bachelor’s degree in Pharmacy, Healthcare Administration, or a related field (Master’s or additional certification in Regulatory Affairs preferred). Minimum of 3-5 years of experience in a compliance role within the pharmacy, healthcare, or pharmaceutical industry. In-depth knowledge of Canadian pharmacy laws, regulations, and industry standards. Familiarity with Health Canada regulations, NACRS, DIN, and NDC codes. Experience conducting audits, investigations, and implementing corrective action plans. Strong understanding of regulatory frameworks and their practical application in pharmacy operations. Excellent organizational, analytical, and problem-solving skills.Detail-oriented with the ability to manage multiple compliance initiatives simultaneously. Strong verbal and written communication skills, with the ability to communicate complex regulatory information clearly.Ability to work independently, as well as part of a multidisciplinary team. Experience in training and educating staff on regulatory and compliance issues.
Certifications:
Certification in Regulatory Affairs or Compliance Management is an asset. Licensure as a Pharmacist in Canada (if applicable, depending on organizational structure).
This job description represents the general responsibilities and duties of the position but should not be construed as an all-inclusive detailed job description.
