Regulatory Affairs Specialist
The Regulatory Affairs Specialist assists in obtaining and maintaining government approval for natural health products, cosmetics, drugs, medical devices, and related materials for clients of Source Nutraceutical Inc. Under direction of the Director of Regulatory Affairs, on behalf of client initiatives, liaises with government officials; evaluates scientific evidence and claims in support of regulatory and/or marketing applications; completes formulation and/or label reviews; and, and prepares reports and responses on projects in the field of natural health products, cosmetics, drugs, and medical devices.
Tasks will include:
- Supporting the Director of Regulatory Affairs in planning, managing, and executing regulatory reviews and general consulting requests on behalf of clients.
- Assisting the Director of Regulatory Affairs in maintaining necessary vendor and trade relationships, consistent with the objectives, operating philosophy and desired image of Source Nutraceutical, Inc.
- Compiling, preparing and reviewing Health Canada regulatory submissions for registration of natural health products, medical devices, drugs and cosmetics as well as responding to government inquiries
- Coordinating requests for (and receipt of) regulatory and quality assurance data requirements from clients.
- Effectively interpreting, applying, and clearly communicating relevant Canadian regulations and policies both to clients and fellow Team members.
- Recognizing and understanding critical components and processes of relevant regulatory applications.
- Evaluating scientific evidence to support claim portfolios within regulatory applications and/or marketing materials.
- Reviewing technical quality documents (i.e. batch records, certificates of analysis and specification sheets) for completeness, accuracy and regulatory compliance; identifying errors, missing information and deviations; reviewing laboratory and stability results and OOS [out-of-specification] results (where applicable); confirming product releases and product stability, comparing results to current specifications to assure product quality; and using the information to complete regulatory applications.
- Identifying priorities and key issues in complex situations and achieving resolution with minimal assistance.
- Meeting or exceeding all budget objectives for all assigned projects as established through the estimating process and as approved by the Director of Regulatory Affairs.
- Ensuring that the Regulatory Affairs tasks are performed in compliance with regulations established by Health Canada or other applicable country authority and within the quality assurance standards of Source Nutraceutical, Inc. and to the satisfaction of the clients.
- Maintaining client’s records and documentation generated on behalf of the clients in an organized manner and according to the procedures set out by the company.
- Striving continually to maintain state of the art technical knowledge of the business and industry while keeping abreast of government regulations.
Required: Bachelor’s Degree (B.Sc.) in Sciences
Preferred: Masters Degree (M.Sc.) or PhD. in Sciences
A minimum of two to five years experience in a regulatory field relating to Natural Health Products or Over-the-Counter (OTC) drug industry in Operations, Quality Assurance, Quality Control or testing environment.
Skill, Knowledge and Abilities:
Skills and knowledge to identify priority and operational problem areas. The ability to solve problems, execute policies and procedures on projects assigned. Solid understanding of Canadian regulations for medical devices, natural health products and drugs.
Ability to move freely around the facility. Ability to listen, actively participate in and communicate effectively with employees, customers, suppliers and government officials.
Basic statistical and analytical scientific skills, as well as excellent reading, writing and spelling ability to communicate clearly and effectively in the English language (bilingualism preferred) on all technical and business levels.
Office, laboratory, and warehouse environments.
Opportunity for remote working conditions if residing outside Manitoba.