Alcon

Eye Care

Director,RegulatoryAffairsStrategy

$0–0k Lake Forest, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Eye Care
Eligibility Requirements

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

Free ATS check

Applying for this Director, Regulatory Affairs Strategy role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Workday

  • Workday has a multi-step form — save your progress after every section.
  • "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
  • Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
  • Job requisition numbers are useful when following up with HR by email.

ANONYMOUS · UNFILTERED

What do employees actually say about Alcon?

Real rants from real employees. Read before you apply.

Read Company Rants →