Company: MCS Associates
Position: Regulatory Affairs Associate
Location: Mississauga, ON
How to Apply: Please email your application to careers@reenagrp.com

POSITION DESCRIPTION:

A career with MCS Associates provides an opportunity to work with a diverse group of people, from various backgrounds and professions, in an organization that is growing and evolving to make lives better and safer by providing Regulatory Consulting Services.

www.mcs-associates.com

The Regulatory Affairs Associate is responsible for submitting regulatory applications to Health Canada and determines the regulatory strategy for obtaining regulatory clearance for products of our MCS Clients.

KEY RESPONSIBILITIES:

• Prepare, coordinate and supervise regulatory submissions for NHPs, pharmaceuticals and cosmetic products.
• Review product conformance and assure compliance
• Prepare stability protocols and stability reports-based ICH guideline which ensures quality is maintained throughout the shelf life of the product.
• Implement different strategies in order to meet evolving regulatory initiatives.
• Register products according to federal guidelines and regulations of third-party suppliers
• Working closely with marketing, R&D and product development team to streamline product registration to the distribution process.
• Develop and conduct programs to maintain quality standards of raw materials and finished products.
• Prepare and update SOPs in accordance with current Health Canada’s GMP requirements.
• Provide regulatory support to clients within Canada and internationally to meet the Canadian regulatory requirements.
• Conduct literature research on PubMed and traditional reference books as part of product license application.
• Excellent knowledge, comprehension, and application of the Food and Drugs Act, Natural Health Product Regulations and Cosmetic Regulations.
• Manage Site license and Drug Establishment License submissions including new, renewal and amendment applications.
• Working closely with the regulatory body – Health Canada to address inquiries related to compliance.
• Assist in preparation of corrective actions for Non-compliance notices from Health Canada.
• Prepare and coordinate submission for electronic structured product listing for US products.
• Assist third parties in the matter of due diligence including product and operational compliance.

REQUIREMENTS:

• B.Sc in one of the biological or chemical sciences.
• Minimum five years of Canadian relevant experience in Regulatory Affairs and GMP in the Natural Health Products or Pharmaceutical or industry.

APPLYING FOR THIS POSITION:

Please submit your application by email to careers@reenagrp.com. MCS Associates would like to thank all applicants; however only candidates selected for interviews will be contacted.