Manager, Regulatory Affairs Strategy

Alcon•Fort Worth, TX

17h•Onsite

About The Position

This role is part of Alcon’s Quality & Regulatory Affairs function, a team dedicated to ensuring our products meet global regulatory requirements and the highest standards of quality, safety, and compliance as we help people see brilliantly. The Manager, Regulatory Affairs Strategy (Professional Path) is responsible for leading regulatory strategy, compliance, and lifecycle management activities for Alcon’s Dry Eye Ocular Health and Contact Lens Care portfolio. This individual will play a critical role in driving regulatory excellence, supporting business objectives, and enabling timely, compliant access to innovative products across global markets while upholding Alcon’s commitment to quality, compliance, and patient safety.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand, and communicate in English
5 Years of Relevant Experience

Nice To Haves

Strong ability to develop and execute global regulatory strategies for complex medical devices
Proven ability to influence cross-functional stakeholders and senior leadership
Excellent communication, negotiation, and regulatory writing skills
Ability to manage multiple priorities in a fast-paced, matrixed environment
Strong analytical thinking and problem-solving capabilities
Demonstrated commitment to quality, compliance, and patient safety

Responsibilities

Lead and manage multiple regulatory projects, ensuring successful execution of key milestones through effective planning, collaboration, and stakeholder alignment
Develop and execute global regulatory strategies for product registrations, submissions, renewals, supplements, and lifecycle management activities
Serve as the primary regulatory representative, providing guidance on regulatory authority interactions and supporting negotiations to facilitate product approvals
Provide strategic regulatory input for new product development, product changes, process improvements, and post-approval activities
Ensure timely approvals and ongoing maintenance of regulatory approvals for marketed products worldwide
Review and ensure compliance of commercial, promotional, and labeling materials in accordance with applicable regulations and company standards
Interpret and apply global regulatory requirements, translating complex regulations into practical business solutions
Lead post-market regulatory activities, including regulatory inspections, audits, inquiries, reporting requirements, and maintenance of regulatory records
Monitor and assess emerging regulatory trends and global requirements, providing regulatory intelligence and actionable recommendations to stakeholders
Ensure compliance with applicable Good Practice (GxP) regulations, internal procedures, documentation requirements, and training expectations
Drive continuous improvement initiatives that enhance regulatory processes, compliance effectiveness, and operational excellence