Regulatory Affairs Specialist

Regulatory Affairs Specialists perform a proactive role in directing and overseeing the development of new products and maintenance and care of existing marketplace products in the biotechnology industry, and use their specific scientific and regulatory knowledge to provide strategic input to the development process. They represent the company’s interests and objectives while interacting and negotiating with regulatory agencies, and work to ensure product and company regulatory compliance in the pre- and post-approval stages. They seek to anticipate, reduce and manage risks associated with regulations related to product development; to influence and provide feedback to the development of new regulations, policies and guidelines; to be cognizant of reimbursement issues in product development; to ensure the quality and safety of the product; to advise on how products are sold and promoted; and to ensure quality standards of research are met.

 

Regulatory Affairs Specialists work for Canadian bio-economy companies of different sizes (e.g., small, medium, large) and in various bio-economy areas.

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