Sr. Director, Regulatory Affairs, External Ocular Devices

Sr. Director, Regulatory Affairs, External Ocular Devices page is loaded## Sr. Director, Regulatory Affairs, External Ocular Devices locations:
Fort Worth, TXtime type:
Full time posted on:
Posted 2 Days Agotime left to apply:
End Date:
January 24, 2026 (12 days left to apply) job requisition :
R-The Sr. Director, Regulatory Affairs - External Ocular Devices (Management Path) is primarily responsible for developing and driving regulatory strategies for various product portfolios. You will oversee new product registrations and maintenance of those registrations throughout the product lifecycle, while collaborating with global regulatory, marketing, clinical, manufacturing and R&D teams. Specifics include:
* Strategically lead Regulatory Affairs team, ensuring compliance with regulatory requirements.
* Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports.
* Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, ensure rapid and timely approval of products and maintain approval throughout the product lifecycle.
* Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations.
* Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates to ensure timely submission and approvals.
* Oversee creative and innovative approaches to competitive claims development and labeling, advertising and promotional material review and approval for product portfolios, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations.
* Proactively monitor and evaluate the US and OUS regulatory promotional environment by reviewing guidelines, enforcement letters, advisories from key international bodies and attending major industry meetings. Use this intelligence to inform promotional claim strategies.
* Provide US and Global Regulatory promotional perspective to business functions to ensure commercially viable labeling supporting business strategies.
* Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage.
* Support products in either the medical device and/or pharmaceutical/OTC family of products, ensuring adherence to all relevant regulations.
* Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments and overall business outcomes.
* Oversee regulatory assessment and acquisition/integration strategy for all merger and acquisition (M&A) activities.
* Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
* Contribute to the overall compliance of the organization and commit to continuous improvement in operations. 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.
* This role will support the External Ocular devices portfolio.
** What You'll Bring to Alcon
*** Bachelor’s Degree
* The ability to fluently read, write, understand and communicate in English
* 12 Years of Relevant Experience
* 8 Years of Demonstrated Leadership
* Travel: 20% Domestic and International

* Work Location:

Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
* Relocation:
Yes
** How you can thrive at Alcon:
*** Work together with…