Overview
Regulatory Affairs Specialist Jobs in Markham, Ontario, Canada at Probus Logistics
Job Summary
The Regulatory Affairs (RA) Specialist reports directly to the Director of Quality Assurance and Regulatory Affairs to assist in Probus Regulatory Licences (DEL, MDEL, and Site Licence); submit product submission to Health Canada; perform product market release; and ensure compliance 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, and API, 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.
This position requires regular in-person attendance to support client requests and foster a collaborative work environment. The nature of the role involves frequent interaction with clients and team members, which is best facilitated through in-person communication and collaboration.
Essential Functions and Accountabilities
- Advise management on changes by regulatory agencies and government requirements. Provide guidance to organization in interpreting and implementing changes. Provide input into emerging internal and external requirements.
- 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 results to management (as required).
- Responsible for the application, amendments, renewal and upkeeping of Probus and Client’s licenses (DEL, MDEL, Site License and CDS) that Probus is responsible for.
- Completing critical assessments of data and documents to identify gaps compared to regulatory requirements.
- Conduct critical assessments of data, documents, and product labelling, including product monographs, to identify gaps and ensure compliance with regulatory requirements and industry standards.
- Manage market release activities through review of CofA, Batch Certificates, and Executed Batch Records, while overseeing product complaints and regulatory reporting activities (APQR, ADR, MDPR, recalls, etc.) with Health Canada and other regulatory agencies.
Qualifications
KNOWLEDGE, SKILLS AND ABILITIES:
- Experience in Logistics/Warehouse, Supply Chain, Manufacturing/Distribution in a GMP environment.
- Strong understanding of GMP, Food and Drug Act, Medical Device Regulations, Natural Health Products regulation.
- Excellent communication (oral and written)
- Exceptional client-facing skills
- Strategic Thinker and Problem – solving ability.
- Computer literacy required.
WORK ENVIRONMENT:
· Standard Office Environment
· Consistent physical activity efforts necessary to perform the job – walking, standing, sitting, lifting up to 10 kg (non repetitive)
EXPERIENCE:
- 2-5 years of experience handling importation of Drugs, NHPs & Medical Devices, Product Compliant, SOP implementation in a Distribution Environment, regulatory affairs, product submission and/or product market release.
EDUCATION:
Bachelor of Science degree in Biology, Chemistry, Pharmacology, Toxicology, or related Health Sciences.
Job Type: Full-Time, Permanent
Compensation: CA$60,000 – $70,000 annually
Benefits:
- Casual dress
- Company Events
- Dental care
- Extended Health Care
- On-site parking
** This role is filling a vacancy and is expected to report to the office, in person – not a remote or a hybrid position.
** We do not use artificial intelligence during the hiring process.
Title: Regulatory Affairs Specialist
Company: Probus Logistics
Location: Markham, Ontario, Canada