Vice President - Regulatory Affairs

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VICE PRESIDENT - REGULATORY AFFAIRS

This position will provide leadership and coaching, along with regulatory and pharma science knowledge to the company's portfolio of products. The person will provide direction and oversight to the North American regulatory system to support company growth.

The VP will have extensive experience leading global regulatory mandates of generic pharmaceutical products, while providing expertise from conceptualization to commercialization.

The VP will need a strong understanding of all departments within development, including R&D, Clinical, QA, Production - while developing global regulatory strategies.

Responsibilities:

• Lead and develop the Canadian and US teams and their respective portfolios, dedicated to Health Canada and FDA regulations.
• Develop best practices into pre- and post-approval product lifecycle management, i.e. change controls, labelling, product launch. With integration of docuBridge, TrackWise & BLUE software systems.
• Ensure collaboration with other departments to ensure supply to market.
• Provide regulatory expertise related to product development, along with regulatory insight and direction on the company's pipeline of products.
• Lead and be the liaison with regulatory authorities on pre-NDA/IND/NDS/ANDA meetings.
• Represent the organization and conferences and associations.
• Develop KPIs to measure performance against benchmarks.
• Responsible for developing departmental goals and needs based on company's strategic planning.
• Provide strong leadership and coaching to direct reports and the regulatory team; establish development and succession plans for critical roles and team members.

Requirements:

• University degree in Pharmaceutical Sciences or Chemistry.
• 15+ years of relevant industry experience.
• 10+ years of relevant FDA and Health Canada experience within regulatory affairs.
• 10+ years of senior management experience.
• Proven team and project management skills, Lean Six Sigma designation would be an asset.
• Proven leadership and talent management experience.
• Business acumen, negotiation and vendor relationship skills.
• Proficient in electronic documentation, TrackWise and labelling software systems.
• Experience within regulatory affairs with branded and/or generic pharmaceuticals.