Senior Regulatory Affairs Associate

At Alcon, we are passionate about enhancing sight and helping people see brilliantly. This role is part of Alcon's Quality & Regulatory Affairs function, ensuring products comply with global, local, and internal regulations while meeting the highest quality standards. Responsibilities Coordinate regulatory compliance for Alcon's product portfolio, managing local initiatives and supporting business requests for product and regulatory information. Participate in cross‑functional teams for risk management and produce compliance metrics. Occasionally represent the Regulatory Affairs Manager when required. Provide operational support and execution for LCM work, including user fee requests and data requests to R&D for tender applications. Maintain project status slide decks for regional Regulatory Affairs calls, draft explanation letters, and fulfill other administrative requirements for HA queries. Conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals. Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely approvals. Oversee promotional material approval for the Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with applicable laws, codes, and regulations. Develop regulatory strategies for new product introductions and changes to maintain compliance and drive competitive advantage. Support medical device and/or pharmaceutical products, ensuring adherence to relevant regulations. Adhere to Good Practice (GxP) regulations by following SOPs, maintaining documentation, ensuring quality control, and completing required training. Prepare and submit ROW applications for new projects, with supervision. Assist with LCM work under supervision. Conduct change assessments (RIARs) and perform PPRR work, registration renewals, and TF maintenance. Qualifications Bachelor’s degree or equivalent experience; or high school with 10+ years of directly related experience, associate’s degree with 16+ years, or master’s degree with no minimum experience. Fluent in reading, writing, understanding, and communicating in English. At least 2 years of relevant experience and 1 year of demonstrated leadership. Location: Onsite, Lake Forest, CA. Travel required: 0–10%. EEO Statement Alcon is an Equal Opportunity Employer and participates in E‑Verify. Alcon takes pride in maintaining a diverse environment and adheres to policies that prohibit discrimination in recruitment, hiring, training, promotion, or other employment practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon also commits to providing reasonable accommodation to individuals with disabilities. If a medical condition or disability requires accommodation, please email View email address on click.appcast.io with the details. #J-18808-Ljbffr