SOURCE NUTRACEUTICAL, INC.
Winnipeg, MB, CANADA R3T 1T4
Associate Director, Regulatory Affairs
About Us:
Source Nutraceutical, Inc. (SNI) is a fast-growing company with offices in Winnipeg, Manitoba and Toronto, Ontario. We are an integrated “one-stop shop” for regulatory affairs, packaging and label compliance, creative services and clinical research needs. SNI has a substantial client base that is constantly growing.
If you like helping people and can provide customer service with a high degree of professionalism, keep reading!
SNI offers the opportunity for personal growth, cross training, and career planning development. We offer an environment that is team oriented and focused on continuous improvement.
Tasks will include:
- Has responsibility for Regulatory Affairs activities assigned to them by the Senior Director of Clinical Affairs and Regulatory Strategy, in a manner that meets or exceeds established guidelines set for standard performance.
- Will provide assistance to the business development function of Source Nutraceutical, Inc. in the formulation, development and implementation of project estimates and pricing items to the customers.
- Must maintain a current knowledge and understanding of all related Canadian and U.S. governmental regulations and standards, both for yourself and your direct reports.
- Will act (on behalf of Source Nutraceutical, Inc.) as a client representative with Canadian and U.S. regulators and assessing bodies; obtaining and maintaining government approvals; and conducting discussions/negotiations with government officials.
- Will ensure that all Regulatory Affairs tasks are performed in compliance with regulations established by Health Canada or other applicable country authorities; within the quality standards of SNI; and to the satisfaction of the clients.
- Will perform an internal quality assurance/quality control (QA/QC) role, including peer review of client projects to ensure completeness, accuracy, and regulatory compliance.
Will provide ongoing support and assist Team Members in establishing goals, objectives, policies, and procedures.
Qualifications:
- Required: B.Sc. degree in a relevant area (i.e., science, research, regulations).
- Preferred: M.Sc. or Ph.D. degree in a relevant area (i.e., science, research, regulations).
- A minimum of three (3) years’ experience and two (2) years of management experience in regulatory relating to one (or more) of the following regulated product categories: Foods, NHPs, Dietary Supplements, Cosmetics, and consumer packaged goods.
- A high standard of accuracy and attention to detail.
- A solid understanding of Canadian and US regulations for foods, NHPs/dietary supplements, cosmetics, and consumer packaged goods.
- The ability to listen, actively participate in, and communicate effectively with employees, customers, suppliers, and government officials.
- Striving continually to maintain state-of-the-art technical knowledge of the business and industry while keeping abreast of government regulations.
- The ability to identify priorities and key issues in complex situations, and to achieve resolution with minimal assistance.
- Strong inter-personal, verbal, and written communication skills in English (bilingualism is an asset).
- The ability to exhibit exemplary behavior, ethics, and transparency within the company, when corresponding with clients, regulatory agencies, and colleagues.
- Proficiency with Microsoft Word, Excel, Powerpoint, and Outlook.
- Working knowledge of project management software (i.e., Smartsheet, BOX, SharePoint, Lucid Chart, and/or MS Project) is an asset.
This is a permanent position with an anticipated start date of October 15, 2024.
If you have great communication skills, a keen eye for detail, and the ability to adapt, we want you on our team! Open to remote applicants within North America.
We thank those who apply, however only qualified applicants will be contacted.
