Regulatory Affairs Manager I at U341 Alcon Research, LLC. Company — Lake Forest, CA

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.

• 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!

Alcon Careers

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Compensation and Benefits

Pay Range

130,900.00 - 169,400.00

Pay Frequency

Annual