Project Leader, Regulatory Affairs, Clinical and Innovative Development

The Project Leader, Regulatory Affairs - Clinical and Innovative Development, assumes responsibilities within the Scientific Affairs department to ensure the timely approval and regulatory maintenance of innovative products and participates to various regulatory projects with our corporate partners. Assume responsibility for the registration of innovative products, as well as the maintenance of regulatory compliance for approved products during the post-marketing phase. Manage the preparation of quality regulatory submissions. Prepare meetings with Health Canada. Review product labels and marketing material to ensure compliance with Canadian regulations. Provide regulatory advices to other divisions and/or departments. Participate to product due diligence and related preparation and implementation of regulatory strategies. This position is in Montreal.

Bachelor's degree in Sciences or equivalent. Asset: Master's degree in Sciences, Drug development / Regulatory affairs or healthcare related professional degree. Four (4) to six (6) years’ experience in the regulatory field for innovative products within the pharmaceutical industry Writing CTD summaries experience Good knowledge of the Canadian regulations as well as ability to interpret policies and guidelines.

Good project management skills
Good writing and presentation skills (English and French)
Bilingualism-French/English (speaking/writing)
Good knowledge of Microsoft Office Suite
Asset : eCTD experience and good knowledge of drug development process

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