Manager, Regulatory Affairs Strategy
On-siteFort Worth, Texas, United States
Job Summary
Lead and manage multiple regulatory projects for Alcon's Dry Eye Ocular Health and Contact Lens Care portfolio, ensuring successful execution of key milestones through planning and stakeholder alignment. Develop and execute global regulatory strategies for product registrations, submissions, renewals, and lifecycle management while serving as the primary regulatory representative for authority interactions and negotiations. Provide strategic input for new product development, interpret global requirements, and oversee post-market activities including inspections, audits, and compliance monitoring for marketed products. Ensure timely approvals and ongoing maintenance of regulatory approvals worldwide while driving continuous improvement initiatives to enhance regulatory processes and operational excellence.
Required Qualifications
- 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
- Monday – Friday, 8:00 AM CST – 5:00 CST
- Onsite (Candidates may be considered to sit at other approved Alcon locations)
- Travel Requirements: Up to 10%
Desired Qualifications
- 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
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