Sr. Manager, Regulatory Affairs Strategy

Key Responsibilities

• Lead and oversee multiple projects within the Regulatory Affairs Strategy function, ensuring delivery of regulatory milestones through strong leadership and stakeholder alignment
• Direct regulatory submission strategies, including registrations, supplements, renewals, and lifecycle updates across global markets
• Act as the primary regulatory liaison, guiding teams on interactions with regulatory authorities and supporting negotiations to facilitate approvals
• Provide strategic regulatory input for: New product development, Product and process changes, Lifecycle management activities
• Ensure timely approvals and maintenance of approvals for marketed products
• Oversee and ensure compliance of promotional materials, in accordance with applicable regulations and ethical standards
• Interpret and apply global regulatory requirements to support business objectives and maintain compliance
• Lead post-market activities, including inspections, regulatory inquiries, and maintenance of regulatory records
• Drive regulatory intelligence activities, assessing evolving global requirements and translating them into actionable strategies
• Collaborate with industry associations (e.g., ANSI, Advamed) to influence and stay aligned with regulatory developments

Key Success Factors

• Strong ability to develop and execute global regulatory strategies for complex medical devices
• Deep understanding of implantable medical devices, preferably intraocular or ophthalmic technologies
• Proven ability to influence cross-functional stakeholders and senior leadership
• Excellent communication, negotiation, and regulatory writing skills
• Strong analytical thinking and problem-solving capabilities
• Demonstrated commitment to quality, compliance, and patient safety

What You’ll Bring to Alcon

• 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

How You Can Thrive at Alcon

• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more
• Travel up to 10%

Compensation And Benefits

• Pay Range 152,150.00 - 196,900.00
• Pay Frequency Annual