Senior Manager, Regulatory Affairs

📋 Description

• Strategically support and/or prepare the filing, approval, and post-approval activities of several
• Hold self and all direct reports accountable for regulatory-related projects and ensure regulatory
• Supervise, manage, support and mentor direct reports.
• Conduct mid- and year-end performance evaluations with each direct report and provide timely
• Review and assist in the evaluation of regulatory submission documents for conformance with Health
• Support the preparation and conduct of pre-submission meetings with Health Canada. This includes

🎯 Requirements

• Bachelor’s degree in Pharmacy, Biology, Pharmacology, or related Life Sciences is required
• Preferred Master of Science degree or Doctorate in Biochemistry, Biology, Microbiology, Chemistry
• Minimum of ten years of experience in the pharmaceutical industry
• Minimum of four years of experience in leading a team of professionals
• Proven success in the preparation, filing, and approval of various submission types with Health
• Developed expertise in the field of Regulatory Affairs, and a good understanding of the Business