Director, Global Regulatory Affairs Strategy (NPD/OH)

Overview

At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. This role is part of Alcon’s Quality & Regulatory Affairs function, ensuring products meet global, local, and internal regulations and high quality standards. The Director, Regulatory Affairs Strategy (NPD/OH) (Management Path) directs product registration, provides strategic guidance, and negotiates with regulatory agencies to secure timely product approvals. You will serve as a regulatory liaison, advising on product development, safety, and compliance while leading a department to align strategies with company goals.

Responsibilities

• Lead a team within Regulatory Affairs, developing and implementing strategies aligned with company goals.
• Lead preparation of global regulatory plans and product strategies for assigned products.
• Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports.
• Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies.
• Ensure rapid and timely approval of products and their continued approval.
• Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities.
• Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies.
• Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations.
• Oversee regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals.
• Provide regulatory strategies and risk assessments/mitigation plans for new product introductions and product changes, maintaining regulatory compliance.
• Support products in the medical device and/or pharmaceutical family, ensuring adherence to relevant regulations.
• Ensure compliance with GxP regulations, SOPs, and quality control, maintaining accurate documentation and completing required training.
• Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions.
• Focus on talent development to enhance capabilities.
• Manage post-approval commitments and lifecycle management.
• Lead and supervise regulatory associates, ensuring synergy across projects and driving competitive advantage through strategic decision‑making.
• Ensure all associates adhere to GxP regulations by following SOPs, maintaining documentation, ensuring quality control, and completing required training; comply with regulatory requirements and commit to continuous improvement.

What You'll Bring to Alcon

• Bachelor's Degree or equivalent experience (or alternative combinations as listed)
• Fluent in English (reading, writing, understanding, and speaking)
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership

• Travel: Minimal
• Work Location: Onsite – Fort Worth, TX (role may be based at other Alcon locations due to business needs)
• Relocation Assistance: Yes
• Sponsorship: None

How you can thrive at Alcon

• Collaborate with colleagues to share standard methodologies and discoveries as work progresses.
• Explore growth and development possibilities to advance your career.
• Join Alcon's mission to provide innovative products and solutions to improve sight and lives, while growing your career.
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and more.

Alcon Careers

See your impact at alcon.com/careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please apply via the Internal Career site.

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon is committed to maintaining an inclusive environment that values diverse perspectives. Our policies are non-discriminatory in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon provides reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please email with the nature of your request and contact information.

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