Senior Director, Regulatory Affairs Strategy & Business Development

About the role

Alcon is seeking a Senior Director to lead Regulatory Affairs Strategy and Business Development & Licensing (BD&L). The role will shape global regulatory plans, drive product registrations, and support business growth while ensuring compliance with all applicable regulations.

Key responsibilities

• Lead multiple departments within the Regulatory Affairs function, providing strategic direction and ensuring regulatory compliance.
• Develop and execute global regulatory plans and product strategies for assigned portfolios.
• Manage regulatory support for business development, licensing, and due‑diligence activities aligned with corporate strategy.
• Direct the preparation and submission of product registrations, supplements, amendments, and periodic reports.
• Negotiate evidence requirements with regulatory agencies to secure timely approvals.
• Advise development and commercial teams on safety, efficacy, manufacturing changes, labeling, and regulatory interpretations.
• Coordinate cross‑functional regulatory activities, ensuring seamless communication between plants, agents, and external partners.
• Provide risk assessments and mitigation strategies for new product introductions and changes.

Required profile

• Extensive experience in regulatory affairs for medical devices and/or pharmaceuticals.
• Proven leadership of large, cross‑functional teams.
• Strong track record of successful product registrations and regulatory negotiations.
• Ability to align regulatory strategies with overall business objectives.
• Excellent communication and stakeholder management skills.

Required skills

What we offer

• Opportunity to influence global regulatory strategy at a leading eye‑care company.
• Collaborative, inclusive culture with career growth potential.
• Competitive benefits and resources to support your success.