Senior Manager, Regulatory Affairs Strategy

At Alcon, we are passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate, champion progress, and act swiftly to impact global eye health. Responsibilities Develop and execute regulatory strategy for pipeline products. Lead cross‑functional teams and influence business strategies to address regulatory needs. Oversee end‑to‑end regulatory support for anterior/posterior ophthalmologic products, including new products, sustaining legacy products, and product line improvements. Manage multiple projects within the Regulatory Affairs Strategy team, ensuring goals are met through self‑directed work and effective supervision. Coordinate regulatory activities—product submissions, renewals, and updates—liaising with plants, agents, and governmental authorities for timely approvals. Oversee promotional material approval for the Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations. Provide regulatory strategies for new product introductions and product changes to maintain compliance and drive competitive advantage. Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations. Make decisions impacting project performance, using project management, advanced problem‑solving, and effective communication. Adhere to GxP regulations by following Standard Operating Procedures (SOPs) and maintaining accurate documentation. Qualifications Bachelor’s degree or equivalent experience; or high‑school +15 years, Associate +11 years, M.S. +4 years, Ph.D. +3 years. Minimum 7 years of relevant experience. 5 years of demonstrated leadership. Proficient in written and verbal English. Ability to read, write, understand, and communicate in English fluently. Residency: Onsite, Lake Forest, CA. Travel requirement: 5–15%. Benefits Alcon provides a robust benefits package that includes health, life, retirement, flexible time off for exempt associates, and paid time off for hourly associates. Compensation Salary range: $167,450.00 – $216,700.00 (annual). Actual compensation may vary based on experience, skills, location, and internal equity. Equal Opportunity Statement Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon respects diversity and does not discriminate on the basis of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, or disability. Reasonable accommodations will be provided for qualified individuals with disabilities. #J-18808-Ljbffr Alcon MX