Our client has a full-time permanent Hybrid position available for a Project Leader, Regulatory Development in Toronto, ON 

Position Summary:

Responsible for the Regulatory Affairs (RA) project management of development and marketed products.

Key Responsibilities:

•Provide regulatory strategic and operational input to local and global teams for development and marketed products throughout their lifecycle.

•Develop and execute filing strategies, including assessing and summarizing scientific and clinical information, where applicable.

•Organize and coordinate meetings with Health Canada.

•Ensure the preparation of high-quality regulatory submissions in alignment with internally defined strategies to meet agreed upon timelines and in compliance with Health Canada Regulations.

•Participate in cross-functional meetings with internal stakeholders (locally and globally), providing subject matter expert input on product strategies.

•Ensure the ongoing compliance for marketed products, specifically through product monograph and label updates/revisions.

•Review and approve promotional and non-promotional material in accordance with regulatory requirements.

•Maintenance of internal databases in timely manner as required for portfolio of products.

Key Requirements:

•BSc. (required), or a degree in a health-related field.

•Minimum of 5-7 years of experience in Regulatory Affairs.

•Demonstrated success in a regulatory environment (e.g., leading a major submission).

•Good knowledge of the current Health Canada regulations and PAAB guidelines.

•Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity).

•Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills).

•Able to manage and influence key stakeholders.

•Fosters innovation (i.e., embraces new insights, concepts, trends & processes).

•Works well independently as well as in a group environment.

Languages: 

•English (written and spoken)

•French is an asset

Computer Knowledge:

•MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat

•Veeva Vault database familiarity is an asset

Travel: 

•Occasional