Manager, Regulatory Affairs Strategy

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?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.Specifics Include:Lead and manage multiple regulatory projects, ensuring successful execution of key milestones through effective planning, collaboration, and stakeholder alignmentDevelop and execute global regulatory strategies for product registrations, submissions, renewals, supplements, and lifecycle management activitiesServe as the primary regulatory representative, providing guidance on regulatory authority interactions and supporting negotiations to facilitate product approvalsProvide strategic regulatory input for new product development, product changes, process improvements, and post-approval activitiesEnsure timely approvals and ongoing maintenance of regulatory approvals for marketed products worldwideReview and ensure compliance of commercial, promotional, and labeling materials in accordance with applicable regulations and company standardsInterpret and apply global regulatory requirements, translating complex regulations into practical business solutionsLead post-market regulatory activities, including regulatory inspections, audits, inquiries, reporting requirements, and maintenance of regulatory recordsMonitor and assess emerging regulatory trends and global requirements, providing regulatory intelligence and actionable recommendations to stakeholdersEnsure compliance with applicable Good Practice (GxP) regulations, internal procedures, documentation requirements, and training expectationsDrive continuous improvement initiatives that enhance regulatory processes, compliance effectiveness, and operational excellenceWHAT YOU’LL BRING TO ALCON: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 English5 Years of Relevant ExperienceWork hours: Monday – Friday, 8:00 AM CST – 5:00 PM CSTLocation: Onsite (Candidates may be considered to sit at other approved Alcon locations)Travel Requirements: Up to 10%Sponsorship & Relocation: Not AvailablePREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:Strong ability to develop and execute global regulatory strategies for complex medical devicesProven ability to influence cross-functional stakeholders and senior leadershipExcellent communication, negotiation, and regulatory writing skillsAbility to manage multiple priorities in a fast-paced, matrixed environmentStrong analytical thinking and problem-solving capabilitiesDemonstrated commitment to quality, compliance, and patient safetyHOW TO THRIVE AT ALCON:Collaborate with teammates to share standard processes and learnings as work evolves!See your career like never before with focused growth and development opportunities!Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!Alcon Careers:​See your impact at alcon.com.careersATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.Find Jobs for EmployeesFind Jobs for Contingent WorkerALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFYAlcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to View email address on click.appcast.io and let us know the nature of your request and your contact information.SummaryLocation: Fort Worth, Texas; Fort Worth, TX; Fort Worth - MainType: Full time