Director, Global Regulatory Affairs Strategy (NPD/OH)

About the role

Alcon is seeking a Director to lead Global Regulatory Affairs Strategy for new product development and over‑the‑counter (OTC) health solutions. The role reports to the Quality & Regulatory Affairs function and is responsible for guiding product registration, regulatory negotiations, and ensuring timely approvals worldwide.

Key responsibilities

• Lead a regulatory affairs team to develop and implement global regulatory plans aligned with company objectives.
• Direct preparation and submission of product registrations, supplements, amendments, and periodic experience reports.
• Negotiate evidence requirements and approval pathways with health authorities.
• Provide strategic guidance on product safety, efficacy, labeling, and manufacturing changes.
• Serve as the regulatory liaison for marketing, research, and commercial teams.
• Oversee post‑approval commitments, lifecycle management, and risk mitigation strategies.
• Ensure compliance with GxP regulations, SOPs, and quality standards.
• Drive talent development and cross‑project synergy within the regulatory team.

Required profile

• Director‑level experience in regulatory affairs for medical devices and/or pharmaceuticals.
• Proven track record of leading global product registration and regulatory strategy.
• Strong understanding of GxP, SOPs, and quality system requirements.
• Excellent communication skills to interact with health authorities and internal stakeholders.

Required skills

• Regulatory strategy development
• Product registration and submission processes
• GxP compliance
• Negotiation with regulatory agencies
• Risk assessment and mitigation planning

What we offer

• Opportunity to influence global eye‑health products.
• Collaborative, inclusive culture with career growth pathways.
• Competitive benefits and resources to support professional development.