Extensive experience in regulatory affairs for contact lens and vision care medical device products
Demonstrated experience with global regulatory strategies for novel or first-in-class medical devices, including early-stage health authority engagement
Familiarity with pediatric device regulatory requirements and clinical study design considerations
Experience with Veeva RIM or equivalent regulatory information management systems
Experience supporting BD&L regulatory due diligence is a strong plus
How You Can Thrive at Alcon:
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 and much more.
Travel up to 10%
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Benefits
Health insuranceVision insuranceFlexible schedule
Additional Information
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?
Alcon is looking to hire a Sr. Manager Global Regulatory Strategy that will lead regulatory strategy development for emerging and next generation contact lens technologies spanning new product development (NPD), lifecycle management, and business development & licensing (BD&L) activities.
This role is on-site in our Fort Worth, Texas or Johns Creek, GA location and a typical day would include:
Portfolio Scope:
Develop global regulatory strategies for novel contact lens platforms , including new optical designs, and innovative material compositions - many of which are early-stage with wearing modality, indication, material, and branding still to be determined.
Lead regulatory strategy for new therapeutic and specialty indications , with particular attention to pediatric populations and evolving global regulatory frameworks
Drive cross-brand lifecycle initiatives , including multi-product labeling changes (e.g., harmonized Instructions for Use), and cross-portfolio regulatory impact assessments
Provide regulatory due diligence and strategic guidance for BD&L opportunities , evaluating regulatory pathway complexity, risk, and timeline implications for potential partnerships, acquisitions, or in-licensing agreements
What Makes This Role Unique:
You will serve as the GRA lead on cross-functional teams for foundational platform technologies intended to enable future product families - requiring comfort with ambiguity and the ability to provide strategic regulatory direction when the product profile is not yet fully defined
You will define market-specific classification and registration strategies across priority jurisdictions (US FDA, EU MDR, China NMPA, Health Canada , China NMPA, Japan PMDA and others), including assessment of higher-risk classification pathways for novel indications.
You will engage with health authorities proactively through pre-submission interactions and advisory meetings to establish regulatory precedent for first-in-class technologies
You will partner closely with R&D, Clinical, and Commercial teams from ideation through launch, translating early technical and clinical data into actionable regulatory strategies
You will contribute to regulatory digital transformation , including utilization of Veeva RIM and emerging AI-enabled tools for submission planning.
What You'll Bring to Alcon:
Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
5 Years of Demonstrated Leadership
Alcon · Fort Worth, TX