Regulatory Affairs Manager I

alcon; Lake Forest (CA); On-site; USD 130,900 - 169,400; Full time

Benefits offered by this job

Health benefits

Retirement plans

Flexible time off

Job summary

Alcon is seeking a Manager I in Regulatory Affairs Strategy to coordinate compliance activities and lead projects in Lake Forest, California. This role involves collaboration with various stakeholders to secure product approvals and drive regulatory strategies.

The ideal candidate will have a Bachelor’s Degree, 5 years of relevant experience, and 3 years of leadership experience. Alcon offers a comprehensive benefits package and opportunities for professional growth.

Qualifications

• 5 years of relevant experience in Regulatory Affairs.
• 3 years of demonstrated leadership experience.
• Fluency in reading, writing, and communicating in English.

Responsibilities

• Coordinate regulatory affairs activities including product submissions.
• Manage individual projects to enhance performance.
• Ensure compliance with Good Practice regulations.

Skills

Leadership

Regulatory compliance

Communication

Project management

Education

Bachelor’s Degree or Equivalent

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?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. You will build effective relationships with plants, agents, and authorities to secure timely approvals and provide regulatory strategies for new products and changes. Occasionally, you will represent the Regulatory Affairs Senior Manager, when requested.

In this role, a typical day will include:

• Responsible for Lifecycle Management projects on lasers, accessories, and microscopes. Change Assessments and associated work, including advertising and promotion review.
• Manage individual projects within the Regulatory Affairs Strategy team to enhance project performance and operational efficiency
• Coordinate product submissions, renewals, and updates by communicating with plants, agents, and authorities
• Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with laws and regulations
• Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage
• Support medical device and 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
• Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed)
• Support post-market inspection and explain approved information to customers
• Maintain approval information in internal systems
• Focus on talent development to enhance capabilities and lead and mentor a team of professionals in Switzerland, driving operational efficiency and high performance

What you’ll bring to Alcon:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience
• 3 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.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range

130,900.00 - 169,400.00

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.