The Associate Director of Regulatory Affairs and Quality Assurance assists in obtaining and maintaining government approval for natural health products (dietary supplements), cosmetics, medical devices, over-the-counter drugs, and consumer packaged goods in the Canadian marketplace. Reporting to the Director of Regulatory Affairs, the Associate Director will perform a Quality Assurance function in reviewing technical documents to ensure accuracy and compliance of regulatory filings, as well as providing technical support to client research and development initiatives.
Tasks will include:
- Supporting the Director of Regulatory Affairs in planning, managing, and executing regulatory reviews and general consulting requests on behalf of clients.
- 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.
- Compiling, preparing, and reviewing Health Canada regulatory submissions for natural health products (product and site licenses), cosmetics, medical devices, over-the-counter drugs, and consumer packaged goods.
- Responding to government inquiries on client regulatory application files, preparing concise accurate responses in a timely manner.
- Reviewing technical quality documents such as 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 (where applicable).
- 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.
- Ensuring projects are continuously completed and delivered on time – both internally, and externally (to 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.
- 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.
- Striving continually to maintain state of the art technical knowledge of the business and industry while keeping abreast of government regulations.
REQUIREMENTS
Education:
Required: Bachelor’s Degree in Human Health and Nutrition; Biological Science; Biotechnology; Food Science; or a related discipline
Preferred: Masters Degree or PhD. in Human Health and Nutrition; Biological Science; Biotechnology; Food Science; or a related discipline
Experience:
A minimum of five (5) years experience in Regulatory Operations, Quality Assurance, Quality Control or testing environment, along with one (1) year in management, in a regulatory field relating to natural health products, cosmetics, medical devices, over-the-counter drugs and/or consumer packaged goods.
Skill, Knowledge and Abilities:
A high standard of accuracy and attention to detail. Skills and knowledge to identify priority and operational problem areas. The ability to solve problems, execute policies and procedures on projects assigned. Strong inter-personal skills. A solid understanding of Canadian regulations for medical devices, natural health products and drugs. Proficiency with Microsoft Word, Excel, and Office. Working knowledge of project management software (i.e., Smartsheet and/or MS-Project) is an asset.
Physical:
Ability to move freely around the facility. Ability to listen, actively participate in and communicate effectively with employees, customers, suppliers and government officials.
Mental:
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 [French] preferred) on all technical and business levels. A desire to maintain and/or improve current knowledge of relevant regulations pertaining to the job function, via ongoing professional development activities (i.e., internal training and/or industry educational opportunities; professional affiliations with industry associations).
Working Conditions:
Office, laboratory, and warehouse environments.
Opportunity for remote working conditions if residing outside Manitoba but only within Canada
We are always looking for talented team members. If you are interested in joining Source Nutraceutical, Inc send in your CV at [email protected]
