- BSc or higher degree with 8+ years' experience in regulatory affairs
- Manager or group leader experience in the pharma industry
- Knowledge of the regulatory submissions process for Health Canada
Manager, Regulatory Affairs - PharmaToronto, ON, Canada
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Manager, Regulatory Affairs - Pharma
The employee with manage all pre-approval regulatory submissions to Health Canada ensuring compliance to regulatory and ICH guidelines. They will also be esponsible for developing regulatory project plans, review and administration for all pipeline products from development to approval ensuring the dossier is built in a timely and effective manner.
The individual must have broad knowledge and extensive experience with parenteral or other dosage forms including, but not limited to, CMC, Quality and R&D.
· Develop and maintain a strong, competent team to support the timely submission and approval of ANDS and NDS’s to Health Canada, targeting industry leading cycle times
· Accountability for the preparation and finalization of a comprehensive and high-quality dossier to Health Canada
· Manages and reviews correspondence with Health Canada on submission deficiencies
· Manages and oversees the publishing of dossiers and deficiency responses in eCTD format
· Lead and build regulatory inputs into development and technology transfer programs
· Execute due diligence, summarize findings of pipeline dossiers and provide a recommendation to the business team
· Build and maintain a constructive working relationship with key external partners such as contract manufacturing organizations and Health Canada
· Assist regulatory team in overcoming technical, administrative and/or operational challenges with internal and external partners
· Provide leadership, coaching and mentorship to direct reports
· Foster a culture of continuous learning and improvement with regulatory guidelines and internal working instructions
· Propose development and annual goals to Regulatory Director that are aligned with the organization’s corporate and annual strategic initiatives.
· Compile a monthly regulatory report summarizing project status, business impact and proposed solutions to challenges
· Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required. Provides cross-functional review/input from a regulatory, scientific and technical viewpoint
· University degree in Science, Pharmacy, Life Sciences with post-graduate certification in Regulatory Affairs program.
· No less than 8 years of relevant industry experience
· No less than 3 years of relevant Health Canada experience
· Proven team and project management skills; Lean Six Sigma designation would be an asset
· Strong interpersonal and communication skills (oral & written); multi-lingual an asset
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001416
Date Posted: 14/08/2019