Senior Manager, Regulatory Affairs Strategy

About the role

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.

Responsibilities

• Set or execute the regulatory strategy for pipeline products
• Lead and manage regulatory activities, including product submissions, renewals, and updates
• Liaise with plants, agents, and governmental authorities to ensure timely submissions and approvals
• Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations
• Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
• Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations
• Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership

Qualifications

• Location: Onsite, Lake Forest, CA
• Travel Requirements: 5– 15%
• Relocation Assistance: Available
• Sponsorship Available: Not Available

Benefits

• Compensation and Benefits
• Total Rewards Programs