Senior Regulatory Affairs Associate

Alcon; Lake Forest (CA); On-site; USD 103,000 - 133,000; Full time

Job summary

Alcon in Lake Forest, CA is seeking a Regulatory Affairs professional to support product submissions, renewals, and labeling updates within a global RA team.

You will coordinate with plants, agents, and authorities, ensure compliance with GxP, and contribute to strategic regulatory activities while growing your career at a leading eye-care company.

This onsite role requires English fluency and at least 2 years of relevant experience, with leadership exposure.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+16yrs; MS +0 yrs).
• The ability to fluently read, write, understand and communicate in English.
• 2 Years of Relevant Experience
• 1 Year of Demonstrated Leadership

Responsibilities

• Assist with regulatory submissions, renewals, and updates.
• Coordinate with plants, agents, and authorities to ensure timely submissions and approvals.
• Oversee regulatory strategies for new product introductions and changes.
• Ensure adherence to GxP regulations and SOPs with proper documentation.

Skills

English fluency

Regulatory knowledge

Leadership

Education

Bachelor’s Degree or equivalent years of related experience

Job description

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. Are you ready to join us?

In this role, a typical day will include:

• Operational support / execution tasks associated with LCM work
  • Working with Reg. Ops. to complete user fee requests
  • Data requests to R&D for tender applications, one-off requests for country-specific technical information, maintenance of project status master slide deck for regional RA calls, drafting (not signing) explanation letters, and other administrative requirements for HA queries
• Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
• Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals
• Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with laws, codes, and regulations
• Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage
• Support medical device and/or pharmaceutical products, ensuring adherence to relevant regulations
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training
• ROW submissions for new projects, with supervision
• Assistance with LCM work, with supervision
  • Change assessments / RIARs
  • PPRR work, registration renewals, TF maintenance, etc.
• Operational support / execution tasks associated with LCM work
  • Working with Reg. Ops. to complete user fee requests
  • Data requests to R&D for tender applications, one-off requests for country-specific technical information, maintenance of project status master slide deck for regional RA calls, drafting (not signing) explanation letters, and other administrative requirements for HA queries

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+16yrs; M.S.+0 yrs) The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience
• 1 Years of Demonstrated Leadership
• Location: Onsite Lake Forest, CA
• Travel Requirements: 0 – 10%
• Relocation Assistance: Not Available
• Sponsorship Available: Not Available

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolves!
• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Compensation And Benefits

Alcon’s Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long‑term value. Our compensation approach includes a combination of fixed and variable pay, with short‑term and long‑term incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and well‑being, provide financial security, and support retirement planning.

Pay Range

102,850.00 - 133,100.00

Pay Frequency

Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.