Alcon
Eye Care
Director,RegulatoryAffairsStrategy
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“Director, Regulatory Affairs Strategy at Alcon. Skills: Regulatory Affairs, Strategy Development, Team Leadership, Regulatory Submissions. Develop and execute regulatory strategies. Obtain and maintain product approvals”
What You'll Achieve.
Obtain and maintain product approvals; Ensure timely product approvals; Ensure ongoing compliance and business continuity; Ensure adherence to relevant regulations; Maintain regulatory compliance; Achieve timely approvals and compliance
Industry & Context.
Adhere to GxP regulations, Strictly follow Standard Operating Procedures (SOPs)
What They're Looking For.
Must Have
Bachelor's Degree or Equivalent years of directly related experience, Ability to fluently read, write, understand, and communicate in English, 10 Years of Relevant Experience, 6 Years of Demonstrated Leadership
What You'll Do.
Develop and execute regulatory strategies
Obtain and maintain product approvals
Provide strategic regulatory leadership
Prepare and oversee regulatory submissions
Serve as liaison with health authorities
Lead and develop regulatory teams
Drive lifecycle management strategies
Ensure ongoing compliance
Lead a department within Regulatory Affairs Strategy
Implement strategies for success
Direct development and submission of registrations
Provide strategic product direction
Negotiate evidence requirements with agencies
Ensure rapid and timely product approval
Serve as regulatory representative
Advise on new product development
Oversee regulatory affairs activities
Ensure timely submission and approvals
Oversee promotional material approval
Provide regulatory strategies for introductions
Support products in medical device family
Collect and analyze regulations/standards
Support post-market inspection
Enhance capabilities through talent development
Lead globally aligned regulatory strategies
Manage post-approval commitments
Guide teams on product development
Coordinate regulatory activities
Lead and supervise regulatory liaisons
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with R&D, Quality, Manufacturing, and Commercial partners; Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies; Interact with health authorities
Communication Scope
Communicate in English
Full Job Description
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a **Director, Regulatory Affairs Strategy (Management Path)** supporting Alcon’s **Quality & Regulatory Affairs** organization, this **onsite role based at our Lake Forest, California main campus** is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios. This position plays a critical role in ensuring products and processes meet global, regional, and local regulatory requirements. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals. Additional responsibilities include leading and developing regulatory teams, collaborating cross‑functionally with R&D, Quality, Manufacturing, and Commercial partners, and driving lifecycle management strategies to ensure ongoing compliance and business continuity. The Director will be responsible for the Consoles sub-team within the Consoles, Consumables & Accessories, and Digital Health (CCD) organization of the Instrumentation GRA franchise. This role is part of Alcon’s Quality & Regulatory Affairs function, ensuring products meet the highest standards of quality, safety, and regulatory compliance. All associates are required to adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, completing re
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