Director, Regulatory Affairs Strategy
Alcon
full-time
Posted on:
Location Type: Office
Location: Lake Forest • California • Texas • United States
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Job Level
About the role
- Developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios
- Providing strategic regulatory leadership across the product lifecycle
- Preparing and overseeing high‑quality regulatory submissions
- Serving as the primary liaison with global health authorities to support timely product approvals
- Leading and developing regulatory teams
- Collaborating cross‑functionally with R&D, Quality, Manufacturing, and Commercial partners
- Driving lifecycle management strategies to ensure ongoing compliance and business continuity
- Advising development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations
- Overseeing regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals
- Supporting post-market inspection and explaining approved information to customers
Requirements
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs.; Assoc.+14 yrs.; M.S.+7 yrs.; PhD+6 yrs.)
- The ability to fluently read, write, understand, and communicate in English.
Benefits
- health, life, retirement, flexible time off, and much more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory submissionslifecycle managementproduct approvalssafety regulationsefficacy regulationsmanufacturing changeslabeling regulationspost-market inspection
Soft Skills
strategic leadershipcollaborationcommunicationteam developmentadvising
Certifications
Bachelor’s DegreeM.S.PhD