The Regulatory Affairs Specialist assists in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials for clients of Source Nutraceutical Inc. Under direction of the Director of Regulatory Affairs, aids in the review of formulations, labels, development of marketing materials, liaising with government officials, and preparation of reports and responses on projects in the field of natural health products, cosmetics, food regulations, medical devices and drugs.
- Supporting the Director of Regulatory Affairs in planning, managing, and executing regulatory reviews and general consulting for clients.
- Reviewing technical documents such as batch records, certificates of analysis and specification sheets for completeness, accuracy and regulatory compliance, and using the information to complete government documents.
- Compiling, preparing and reviewing Health Canada regulatory submissions for registration of medical devices, drugs and natural health products, as well as responding to government inquiries.
- 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.
- Assist 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.
- Strive continually to maintain state of the art technical knowledge of the business and industry while keeping abreast of government regulations.
- Required: Bachelor’s Degree in Sciences
- Preferred: Masters Degree or PhD. in Sciences
- A minimum of two (2) years experience in a regulatory field relating to Natural Health Products, Medical devices, or 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.
Please submit a cover letter and resume, along with salary expectations by Friday August 27, 2021 to firstname.lastname@example.org.
We thank those who apply however only qualified applicants will be contacted.