Regulatory Affairs Specialist

Full Job Description

The Regulatory Affairs Specialist assists in managing Regulatory Licences (DEL, MDEL, and Site Licences); prepare product submission to Health Canada; perform product market release; and ensure clients are compliant with current and changing regulatory regulations. This position supports the development, maintenance and implementation of the quality compliance programs and quality systems related to drug, natural health products, medical devices, API, and food. This position supports the implementation of Quality Strategic Objectives and supports the verification and monitoring of the effectiveness of the company quality system and its compliance to applicable regulations and standards.

Responsibilities:

• Advise management on changes by regulatory agencies and government requirements. Provide guidance to organizations in interpreting and implementing changes. Provide input into emerging internal and external requirements.
• Interact and build partnerships with clients, vendors, and service providers.
• Communicate and support resolutions with regulatory authorities on quality and compliance issues.
• Support the oversight of the Quality System Management and report any issues regarding the compliance status and performance of the company.
• Responsible for management of client and regulatory inspections and compliance activities by performing the following duties personally or through direct reports.
• Represents the company during government inspections; Manages regulatory inspections and external audits via preparation, hosting and implementing corrective actions as appropriate. Reporting of results to management (as required).
• Provide Inspection response.
• Lead the implementation and monitor corrective and preventative actions.
• Responsible for the application, revision, renewal and upkeeping of company and Client’s licenses (DEL, MDEL, Site and CDS) that company is responsible for.
• Compile documents, prepare, review, and submit to Health Canada product submission (drugs, NHP, and medical devices).
• Perform review of submission documents, product formulation, product claims, etc. for compliance with Health Canada requirements to identify gaps and weaknesses of submission and provide guidance to stakeholders to ensure compliance with Canadian requirements.
• Review product labelling including product monographs to ensure compliance with regulatory requirements and industry standards.
• Host meetings and communicate (oral and written) with Clients, internal and external stakeholders to provide input, status update, and solution resolutions on projects and regulatory issues.
• Perform product market release for Canadian market.
• Manage product complaints.
• Manage product reporting (APQR, ADR, MDPR, Recalls, etc.) to Health Canada and regulatory agencies.
• Create, review, and revise Standard Operating Procedures.
• Liaise with Health Canada as necessary with regards to inquiries, application/submission, and audits.
• Remain up to date on applicable regulatory regulations and guidelines for drugs, NHP, medical devices and food.
• Assist with Quality Assurance team members as necessary.
• Perform other duties as assigned by RA/QA Management team.

QUALIFICATIONS

• Bachelor of Science degree in Biology, Chemistry, Pharmacology, Toxicology, or related Health Sciences.
• Preference given to 5 or more years’ experience with Health Canada, Medical Devices Regulations, Regulatory Administration, Product Compliant Handling, SOP implementation in a Distribution Environment, GMP, Pharmaceutical, regulatory affairs, product submission and/or product market release.

CORE COMPETENCIES

• Excellent verbal and written expertise and strong interpersonal and collaborative abilities to engage with individuals at all levels, across the organization both internally and externally.
• Strong understanding of GMP, Food and Drug Act, Medical Device Regulations, Natural Health Products regulation.
• Strong project management skills, technical aptitude, and the ability to see the bigger picture.
• Good understanding of Quality systems in a Good Manufacturing Practices (GMP) environment.
• Strong problem-solving and decision-making skills in a team environment.
• Collaborates well with others.
• Strong commitment to quality, exceptional attention to detail, meticulous by nature.
• Strong organization, able to work independently, prioritize deadliness, and must be able to multi-task and manage and meet timelines.
• Ability to exercise initiative, sound judgement and decision making within the scope of authority.
• Fosters an inclusive and respectful work environment for all.