Manager, Regulatory Affairs Strategy

About the role

Alcon is seeking a Manager, Regulatory Affairs Strategy to lead regulatory strategy and lifecycle management for its Dry Eye Ocular Health and Contact Lens Care portfolio. The role will ensure global regulatory compliance, support product approvals, and drive regulatory excellence across markets.

Key responsibilities

• Lead and manage multiple regulatory projects, coordinating milestones, collaboration and stakeholder alignment.
• Develop and execute global regulatory strategies for registrations, submissions, renewals, supplements and lifecycle activities.
• Act as primary regulatory representative, guiding interactions with authorities and supporting negotiations.
• Provide strategic input for new product development, changes, process improvements and post‑approval activities.
• Maintain timely approvals and ongoing compliance for marketed products worldwide.
• Review commercial, promotional and labeling materials for regulatory compliance.
• Interpret global regulatory requirements and translate them into practical business solutions.
• Lead post‑market activities, including inspections, audits, inquiries and regulatory reporting.
• Monitor emerging regulatory trends and deliver intelligence and recommendations.
• Ensure adherence to GxP regulations, internal procedures and documentation standards.
• Drive continuous improvement of regulatory processes and operational excellence.

Required profile

• Bachelor’s degree or equivalent experience in a related field.
• Significant experience in regulatory affairs within the medical or ophthalmic industry.
• Proven ability to manage complex, cross‑functional projects and lead regulatory teams.
• Strong understanding of global regulatory frameworks and product lifecycle management.
• Excellent communication skills for interaction with authorities and internal stakeholders.

Required skills

• Regulatory strategy development
• Regulatory submissions and approvals
• GxP compliance
• Regulatory intelligence and trend analysis
• Post‑market regulatory activities