Director, Global Regulatory Affairs Strategy; NPD​/OH

Director, Global Regulatory Affairs Strategy (NPD/OH) page is loaded## Director, Global Regulatory Affairs Strategy (NPD/OH) remote type:
Not applicable locations:
Fort Worth, Texastime type:
Full time posted on:
Posted 14 Days Agotime left to apply:
End Date:
March 17, 2026 (13 days left to apply) job requisition :
R-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.
Specifics Include:
* 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.
** What You'll Bring to Alcon
*** 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
* Travel:
Minimal

* Work Location:

Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
* Relocation Assistance - Yes
* Sponsorship:
None
** How you can thrive at Alcon:
*** Work together with colleagues to share standard methodologies and discoveries as work progresses.
* Discover your career in a fresh way through specific growth and development possibilities.
* Join Alcon’s mission to provide outstanding, innovative products and solutions to improve…