Senior Manager, Regulatory Affairs
Core
Lead a team of Regulatory Affairs professionals to manage and oversee regulatory submissions for AbbVie's development and marketed products portfolio, including medical devices, ensuring compliance with Health Canada policies.
Role type
Senior Manager, Regulatory Affairs (Team Lead)
Builds
Regulatory submissions (clinical trial applications, new drug submissions, medical device submissions) and Canadian label artwork for AbbVie products.
Domain
Pharmaceutical / Life Sciences / Regulatory Affairs
Required skills
Team leadership and mentorship, regulatory submission strategy, Health Canada compliance, project management, negotiation, stakeholder management, SOP development, audit management, data entry management, training oversight, policy interpretation.
Preferred skills
Master of Science or Doctorate in Life Sciences or Management, experience with biologics/small molecules/medical devices, knowledge of FDA/EMA/CHMP/MHRA requirements, experience with product in-licensing/divestitures/acquisitions.
Technologies
Electronic regulatory submission systems, Canadian Food and Drugs Act databases.
Responsibilities
Strategically support and prepare regulatory filings and post-approval activities; supervise and mentor direct reports; conduct performance evaluations; consult with Global Regulatory team on filing strategies; participate in NPI and launch readiness reviews; manage regulatory activities for acquisitions; lead internal and external inspections/audits; update local SOPs.
Seniority
Senior Manager, hands-on IC with team leadership