Director, Global Regulatory Affairs Strategy (NPD/OH)

Alcon • Fort Worth, TX

11d • Onsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Director, Regulatory Affairs Strategy (NPD/OH) (Management Path) is primarily responsible for directing product registration, providing strategic guidance, and negotiating with regulatory agencies to ensure 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.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership

Responsibilities

• Lead a team within the Regulatory Affairs developing and implementing strategies for success and alignment 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 Good Practice (GxP) regulations, Standard Operating Procedures (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.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
• Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
• Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Director