Sr. Manager Global Regulatory Strategy

Responsibilities

• Lead regulatory strategy development for emerging contact lens technologies, including novel optical designs and innovative material compositions.
• Drive regulatory strategy for new therapeutic and specialty indications, with a focus on pediatric populations and evolving global frameworks.
• Manage cross-brand lifecycle initiatives, such as multi-product labeling changes and regulatory impact assessments.
• Provide regulatory due diligence and strategic guidance for Business Development & Licensing (BD&L) opportunities, including acquisitions and partnerships.
• Define market-specific classification and registration strategies across major jurisdictions such as US FDA, EU MDR, China NMPA, and Japan PMDA.
• Engage proactively with health authorities through pre-submission interactions and advisory meetings.
• Partner with R&D, Clinical, and Commercial teams to translate technical data into actionable regulatory pathways.

Requirements

• Bachelor's Degree or equivalent professional experience.
• 7 years of relevant regulatory experience.
• 5 years of demonstrated leadership experience.
• Fluency in English (reading, writing, and communication).

Preferred Qualifications

• Extensive experience in regulatory affairs for contact lens and vision care medical device products.
• Proven track record with global regulatory strategies for novel or first-in-class medical devices.
• Familiarity with pediatric device regulatory requirements and clinical study design.
• Experience with Veeva RIM or equivalent regulatory information management systems.
• Experience supporting BD&L regulatory due diligence.

Benefits

• Focused growth and development opportunities.
• Robust benefits package including health, life, and retirement plans.
• Flexible time off.

About the Company

Alcon is a global leader in eye care, dedicated to helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly to impact global eye health through advanced surgical equipment and consumer products. We foster an inclusive culture where every contribution helps us make a difference in the lives of patients and customers worldwide.