Sr. Manager Global Regulatory Strategy

Alcon•Fort Worth, TX

14h•Onsite

About The Position

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. The role involves developing global regulatory strategies for novel contact lens platforms, including new optical designs, and innovative material compositions. It also includes leading regulatory strategy for new therapeutic and specialty indications, with particular attention to pediatric populations and evolving global regulatory frameworks. The position drives cross-brand lifecycle initiatives, including multi-product labeling changes and cross-portfolio regulatory impact assessments. Additionally, it provides 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. The unique aspects of this role include serving as the GRA lead on cross-functional teams for foundational platform technologies, defining market-specific classification and registration strategies across priority jurisdictions, engaging with health authorities proactively, partnering closely with R&D, Clinical, and Commercial teams, and contributing to regulatory digital transformation.

Requirements

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

Nice To Haves

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

Responsibilities

Develop global regulatory strategies for novel contact lens platforms, including new optical designs, and innovative material compositions.
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.
Serve as the GRA lead on cross-functional teams for foundational platform technologies intended to enable future product families.
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.
Engage with health authorities proactively through pre-submission interactions and advisory meetings to establish regulatory precedent for first-in-class technologies.
Partner closely with R&D, Clinical, and Commercial teams from ideation through launch, translating early technical and clinical data into actionable regulatory strategies.
Contribute to regulatory digital transformation, including utilization of Veeva RIM and emerging AI-enabled tools for submission planning.