SOURCE NUTRACEUTICAL, INC.
Winnipeg, MB, CANADA R3T 1T4
Director, Regulatory Affairs & Quality Assurance
Source Nutraceutical, Inc. Winnipeg Office – 1-1249 Clarence Ave.
About Us:
Source Nutraceutical, Inc. is a fast-growing company with offices in Winnipeg, Manitoba and Toronto, Ontario. The company is an integrated “one-stop shop” for regulatory affairs, packaging and label compliance, marketing support, and warehousing and order fulfillment needs. Source Nutraceutical, Inc. 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!
Source Nutraceutical offers the opportunity for personal growth, cross training, and career planning development. We offer competitive wages and benefits, free parking and more! We offer an environment that is team oriented and focused on continuous improvement!
The Position:
Under the direction of the Senior Director of Clinical Affairs & Regulatory Strategy, the Director of Regulatory Affairs & Quality Assurance will offer regulatory affairs, quality assurance, strategic consulting, and project management services to the clients of Source Nutraceutical, Inc. (SNI). The Director will implement corporate regulatory strategies, leading to successful client project delivery of regulatory applications, reports, and/or assessments relating to one (or more) of the following product areas: Natural Health Products (NHPs), cosmetics, foods, veterinary health products, medical devices, and drugs.
The Director will be responsible for the oversight of various regulatory-related initiatives, ensuring that project and/or process components are compliant with both internal quality standards and relevant government regulations. The Director will lead a departmental team, providing guidance to regulatory affairs and quality assurance staff members. The Director will also support SNI’s business development initiatives in regulatory affairs- and quality assurance- related areas.
Tasks will include:
- Supporting the Senior Director in planning, managing, and executing regulatory reviews; in developing and implementing regulatory strategies for SNI’s clients; and in developing and maintaining internal quality control processes to ensure organizational standards are met.
- Maintaining a current knowledge and understanding of all related Canadian and U.S. governmental regulations and standards for yourself and your direct reports.
- Ensuring that the Regulatory Affairs and Quality Assurance 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.
- Compiling, preparing, and reviewing Health Canada regulatory submissions for pre- and/or post-market registrations (or notifications), product and/or site licensing, and master files, as well as responding to government inquiries in these same regulatory categories.
- Acting as a representative with Canadian and U.S. regulators and assessing bodies; obtaining and maintaining government approvals; and conducting discussions/negotiations with government officials on behalf of client initiatives.
- Maintaining client records and documentation in an organized manner, and according to the procedures set out by the company.
- Continuously adapting to new Canadian and U.S. regulatory and quality assurance information; monitoring and documenting regulatory compliance updates; and having the ability to integrate all regulatory developments in areas which have the potential to affect SNI’s clients.
- Overseeing the review of 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.
- Meeting or exceeding all budget objectives for all assigned projects as established through the estimating process and as approved by the Senior Director and President.
- Assisting the Senior Director in maintaining necessary vendor and trade relationships, consistent with the objectives, operating philosophy, and desired image of SNI.
- Performing HR staff-related tasks, including (but not limited to) conducting annual performance evaluations of all team members reporting directly to this position, in conjunction with HR; completing departmental payroll; approving vacation requests; validating time entries; ensure staff follow corporate policies; etc.
- Completing invoicing of all projects.
- Ensuring projects are completed and delivered on time – both internally, and externally (to clients and regulatory bodies).
Requirements:
Education:
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).
Experience:
A minimum of five (5) years experience and three (3) years of management experience in regulatory and/or quality assurance field(s) relating to one (or more) of NHPs, foods, cosmetics, medical devices, drugs, veterinary health products, consumer packaged goods, and/or foods.
Skills, Knowledge, and Abilities:
- A high standard of accuracy and attention to detail.
- A solid understanding of Canadian regulations for NHPs, cosmetics, medical devices, drugs, veterinary health products, consumer packaged goods, and/or foods.
- 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.
Working Conditions:
- Office, laboratory, and warehouse environments.
- Opportunity for remote working conditions if residing outside Manitoba.
If you have great communication skills, a keen eye for detail, and the ability to adapt, we want you on our team!
Please send your resume to humanresources@sourcenutra.com before November 30, 2022.
We thank those who apply however only qualified applicants will be contacted.
