This role is part of Alcon's Quality & Regulatory Affairs function, a team dedicated to ensuring our products meet global regulatory requirements and the highest standards of quality, safety, and compliance as we help people see brilliantly.
The Manager, Regulatory Affairs Strategy (Professional Path) is responsible for leading regulatory strategy, compliance, and lifecycle management activities for Alcon's Dry Eye Ocular Health and Contact Lens Care portfolio. This individual will play a critical role in driving regulatory excellence, supporting business objectives, and enabling timely, compliant access to innovative products across global markets while upholding Alcon's commitment to quality, compliance, and patient safety.
Specifics Include:
- Lead and manage multiple regulatory projects, ensuring successful execution of key milestones through effective planning, collaboration, and stakeholder alignment
- Develop and execute global regulatory strategies for product registrations, submissions, renewals, supplements, and lifecycle management activities
- Serve as the primary regulatory representative, providing guidance on regulatory authority interactions and supporting negotiations to facilitate product approvals
- Provide strategic regulatory input for new product development, product changes, process improvements, and post-approval activities
- Ensure timely approvals and ongoing maintenance of regulatory approvals for marketed products worldwide
- Review and ensure compliance of commercial, promotional, and labeling materials in accordance with applicable regulations and company standards
- Interpret and apply global regulatory requirements, translating complex regulations into practical business solutions
- Lead post-market regulatory activities, including regulatory inspections, audits, inquiries, reporting requirements, and maintenance of regulatory records
- Monitor and assess emerging regulatory trends and global requirements, providing regulatory intelligence and actionable recommendations to stakeholders
- Ensure compliance with applicable Good Practice (GxP) regulations, internal procedures, documentation requirements, and training expectations
- Drive continuous improvement initiatives that enhance regulatory processes, compliance effectiveness, and operational excellence
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+0 yrs)
- The ability to fluently read, write, understand, and communicate in English
- 5 Years of Relevant Experience
- Work hours: Monday - Friday, 8:00 AM CST - 5:00 PM CST
- Location: Onsite (Candidates may be considered to sit at other approved Alcon locations)
- Travel Requirements: Up to 10%
- Sponsorship & Relocation: Not Available
PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:- Strong ability to develop and execute global regulatory strategies for complex medical devices
- Proven ability to influence cross-functional stakeholders and senior leadership
- Excellent communication, negotiation, and regulatory writing skills
- Ability to manage multiple priorities in a fast-paced, matrixed environment
- Strong analytical thinking and problem-solving capabilities
- Demonstrated commitment to quality, compliance, and patient safety
HOW TO 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 a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
Alcon Careers:- See your impact at alcon.com.careers
ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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