Sr. Manager Global Regulatory Strategy at U341 Alcon Research, LLC. Company — Fort Worth, TX

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

Preferred Qualifications

• 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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