Senior Manager, Regulatory Affairs
Core
Oversee regulatory activities for assigned pharmaceutical products and projects, serving as the regulatory representative on cross-functional teams to ensure compliance and drive registration strategies.
Role type
Senior Manager, Regulatory Affairs
Builds
Drug product registrations and life-cycle management across North America
Domain
Pharmaceutical industry, Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, Health Authority submissions (FDA/Health Canada), IND/NDA/ANDA/NDS/DMF management, cross-functional team leadership, budget management, timeline management, change control assessments
Preferred skills
Advanced health care discipline degree (PharmD, PhD, Master of Science), experience with drug/device combination products
Technologies
MS Office (via careerplan.io/jobs/4722174005-senior-manager-regulatory-affairs-at-azurity-pharmaceuticals)
Responsibilities
Represent Regulatory Affairs on internal and external cross-functional teams; Provide regulatory assessment for new business development; Serve as primary interface with FDA and Health Canada; Drive regulatory strategies for drug product registration and life-cycle management; Manage regulatory filings including IND, NDA, ANDA, NDS, DMF; Manage operational aspects of compliant submissions; Establish and manage submission timelines; Manage archive of regulatory submissions and correspondence; Provide regulatory guidance on post-approval/life-cycle changes; Provide regulatory support for Senior and Executive Leadership Team meetings; Monitor evolving region-specific regulations; Assist in preparing budgets and reviewing invoices; Participate in setting goals and process improvements within the regulatory department.