Provide strategic and operational regulatory leadership across the biologics product lifecycle
Lead and manage all CMC Regulatory files
Overall responsibility for CMC aspects of regulatory submissions
Manage agency meetings and consulting services
Participate and support project teams with CMC regulatory updates and strategies
Develop and maintain partnerships with senior decision-makers within all departments
Facilitate the preparation and review of complex regulatory packages
Act as CMC regulatory expert for product task force
Effectively prioritize, coordinate and complete multiple projects within established timeframes
Develop and manage regulatory team members
Maintain relevant internal job aids/SOPs

B.Sc. / M.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy)
10-15 years direct CMC experience in Regulatory Affairs with a clear focus on biologics
Authoring/reviewing Module 3
Leadership skills and/or consulting experience
Effective project and people management skills
Strategic planning and problem-solving skills
Direct experience and working knowledge of a wide range of regulatory submissions types
Knowledge of Environment Canada New Substance Regulations
Understanding of Health Canada and FDA regulations related to the CMC regulatory landscape
Strong analytical and mathematical skills
Proficient with Microsoft Word, Excel, PowerPoint and other Office Programs

Director, Regulatory Affairs, CMC-Biologics

Key skills