Director, Regulatory Affairs Strategy

Alcon•Fort Worth, TX

2d•Onsite

About The Position

The Regulatory Strategy job family covers roles responsible for developing and implementing strategies to obtain and maintain product approvals from regulatory agencies in support of Alcon’s franchise portfolios. Professionals in this family collaborate closely with cross‑functional teams, prepare and manage regulatory submissions, drive product lifecycle management, engage in external‑facing interactions with health authorities (HAs), and ensure products and processes align with current regulatory requirements. This onsite role, based at Alcon’s Lake Forest, California main campus, is part of Alcon’s Quality & Regulatory Affairs function, which ensures our products comply with global, regional, and internal regulatory requirements while meeting the highest standards of quality. The Director, Regulatory Affairs Strategy (Management Path) is primarily responsible for directing product registration activities, providing strategic regulatory guidance, and leading negotiations with regulatory agencies to ensure timely product approvals. In this role, you will serve as a regulatory liaison, advising on product development, safety, and compliance while leading a department to align regulatory strategies with company goals. The Director will be responsible for the Consumables & Accessories sub-team within the Consoles, Consumables & Accessories, and Digital Health (CCD) organization of the Instrumentation GRA franchise. 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 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.

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 department within the Regulatory Affairs Strategy team, developing and implementing strategies for success and alignment with company goals
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
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
Oversee promotional material approval, ensuring ethical conduct and compliance with laws and regulations
Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance
Support products in the medical device family, ensuring adherence to relevant regulations
Collect and analyze regulations/standards to ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association (AdvaMed)
Support post-market inspection and explain approved information to customers, maintaining approval information in internal systems
Focus on talent development to enhance capabilities
Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions
Manage post-approval commitments and lifecycle management
Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities
Coordinate regulatory activities for timely approvals and compliance
Lead and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-making