Director, Regulatory Affairs Strategy

Director, Regulatory Affairs Strategy

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.

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.

In this role, a typical day will include:

• 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

Minimum Qualifications:

• 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
• Sponsorship Availability: No
• Relocation Assistance Availability: Yes

HOW TO THRIVE AT ALCON:

• Benefit from working in a highly collaborative environment.
• Join Alcon's mission to provide top-tier, innovative products to enhance sight, enhance lives, and grow your career.
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!