Manager, Regulatory Affairs Strategy
Core
Lead regulatory strategy, compliance, and lifecycle management for Alcon's Dry Eye Ocular Health and Contact Lens Care portfolio.
Role type
Manager, Regulatory Affairs Strategy
Builds
Global regulatory strategies for product registrations, submissions, renewals, and lifecycle management for medical devices.
Domain
Medical Devices / Ophthalmology
Deliverable
client delivery
Required skills
Global regulatory strategy development, lifecycle management, regulatory authority negotiation, compliance interpretation, post-market surveillance, GxP regulations, regulatory intelligence, project management, stakeholder alignment, commercial material compliance review.
Preferred skills
Complex medical device regulatory strategy, cross-functional influence, regulatory writing, analytical thinking, problem-solving.
Technologies
None stated
Responsibilities
Lead and manage multiple regulatory projects ensuring successful execution of key milestones; Develop and execute global regulatory strategies for product registrations, submissions, renewals, and lifecycle management; Serve as primary regulatory representative providing guidance on regulatory authority interactions; Provide strategic regulatory input for new product development and process improvements; Ensure timely approvals and ongoing maintenance of regulatory approvals worldwide; Review and ensure compliance of commercial, promotional, and labeling materials; Interpret and apply global regulatory requirements to create business solutions; Lead post-market regulatory activities including inspections, audits, and inquiries; Monitor and assess emerging regulatory trends providing actionable recommendations; Ensure compliance with GxP regulations and internal procedures; Drive continuous improvement initiatives for regulatory processes.
Seniority
Manager, hands-on IC
