Director, Regulatory Affairs

Ensure that staff has the knowledge and resources to perform as effectively as possible while adhering to and enforcing corporate standards. Where bioequivalence studies are required for products supplied by third parties, ensure that these studies are conducted in accordance in a timely manner to the appropriate scientific and corporate standards. Direct the interactions between RCC and Development Regulatory Centers (DRC), and, where applicable, third parties, ensure (to the degree that is possible) that essential documentation of acceptable quality for submission to TPD is provided in a timely manner and that timely and accurate feedback is provided to the DRCs where required. Ensure compliance with the RCC/DRC Working Instructions. Train the RCC staff and DRC with respect to Canadian requirements is an essential component of this role. Direct the day-to-day interactions with the evaluation groups of Health Canada, developing and maintaining good relations, and thorough diligent follow-up and negotiations, ensuring that regulatory approvals are obtained as early as is possible; Ensure that the regulatory requirements for all post-market product changes are assessed with respect to Health Canada requirements, that these requirements are communicated and implemented in a timely manner, and that all commercialized products maintain the required level of regulatory compliance. Manage the registration process for the Provincial Formularies, Territories, Federal Drug plans and Third Party payers which invloves interactions with Marketing and Sales, Quality, Operations and Business Development; Ensure submisisons are acurately presented, scientifically sound and encompass all relevant material necessary for a complete submission and that the deadlines are met, following up with external stakeholders to facilitate the approval process. Provide requested information in a timely and accurate manner and update formularies of product changes as need be; Handle written and verbal communication with Provincial Government and Third Party representatives in all matters regarding the regulatory process for formulary listing. Assess, and communicate with other Departments (primarily Sales and Marketing), accurate and realistic listing dates. Asses changes to expected listing dates.

Bachelor of Science (Pharmacy, Biochemistry, Chemistry…); Two (2) to five (5) years of managerial experience in the pharmaceutical industry or equivalent; Minimum of five (5) years of Regulatory Affairs experience; Minimum of two (2) years regulatory experience dealing with Health Canada with pharmaceutical products; Experience in preparation/review and approval of regulatory documentation for Canada; Knowledge of Canadian regulatory requirements; Strong ability to effectively manage staff; Excellent verbal and written communication in English; French is an asset Proficiency in the Microsoft Office suite (Word, Excel and PowerPoint) Must demonstrate a high degree of honesty, integrity and respect both with internal and external clients; Excellent analytical skills; Proven ability to adhere to tight deadlines in a constantly changing environment; Self-reliance and the ability to lead and influence in order to achieve results.