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.
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.
- 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.
- B.Sc in one of the biological or chemical sciences.
- Minimum two years of relevant experience in Regulatory Affairs and GMP in the Natural Health Products or Pharmaceutical or industry.
MCS Associates would like to thank all applicants; however only candidates selected for interviews will be contacted.
Operations During COVID-19:
We continue to closely monitor the COVID-19 situation as well we are working to comply with advice being provided by both levels of the Canadian government.
Our parent company, Reena Group provides essential goods and services to the pharmaceutical, food, natural health products and medical cannabis industries, who are playing a pivotal role in responding to the crisis by ensuring the availability of products and supplies necessary to respond medically and economically both in Canada and the United States.
During this unprecedented time, our number one priority is the safety of our employees, customers and communities. To continue to serve our client community, we have proactively adopted modified working practices, staggered working hours and taken all the warranted precautions to mitigate the risk of COVID-19 transmission and to ensure a safe environment to ensure that we comply with the principles of social distancing.
Job Type: Full-time
- Dental care
- Extended health care
- Vision care
- 8 hour shift
- Canadian Regulatory Affairs: 2 years (preferred)
- Remote interview process
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place