Sr. Manager Global Regulatory Strategy

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

• Led 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

Regulatory Due Diligence and Strategic Guidance

• 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

Regulatory Digital Transformation

• 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