Sr Manager, Regulatory Operations Publishing & Registration Management (Devices)

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 Sr. Manager Regulatory Operations (Management Path) is primarily responsible for directing product/process submissions ensuring timely approvals and maintaining high-quality regulatory support. You will lead negotiations to align on optimized regulatory strategies and manage global strategies to enhance product value.

In this role a typical day will include:

• Oversee multiple regulatory operations projects ensuring goals are met through effective management and oversight in support of medical device and/or pharmaceutical products
• Lead teams responsible for dossier preparation Clinical Trial Disclosure submission management submission publishing licensing and labeling ensuring timely and accurate submission of regulatory documents
• Make key decisions impacting project performance and success
• Apply project management advanced problem-solving effective communication leadership and industry-specific knowledge
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs) maintaining accurate documentation and ensuring quality control
• Commit to continuous improvement and compliance with regulatory requirements

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 15 yrs; Assoc.11 yrs; M.S.4 yrs; PhD3 yrs)
• The ability to fluently read write understand and communicate in English
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Location: Onsite- Fort Worth TX Lake Forest CA
• Schedule: 1st Shift: Monday - Friday
• Travel Requirements: 0-10%
• Sponsorship & Relocation: Not Available

Preferred Qualifications/Skills/Experience:

• Demonstrate deep expertise in the regulatory submission lifecycle and associated processes for Class I Class II and Class III medical devices across the United States European Union and Canada
• Possess comprehensive knowledge of key regulatory submission platforms and portals including the U.S. Food and Drug Administration (FDA) electronic Submission Template and Resource (eSTAR) Health Canada Regulatory Enrolment Process (REP) and European Union Notified Body submission portals.
• Experienced in managing export certification activities through the Center for Devices and Radiological Health (CDRH) Export Certification Application and Tracking System (CECATS) including Certificates to Foreign Government (CFG) Certificates of Exportability (COE) and European Union Free Sale Certificates (FSC).
• Lead the optimization and standardization of apostille notarization legalization and country-specific documentation processes to support international regulatory submissions accelerate approval timelines and improve operational efficiency.
• Serve as a subject matter expert on global registration and submission pathways providing strategic guidance for regulatory submissions and market access activities across the U.S. EU Canada and international markets.
• Identify and implement process improvements that reduce submission cycle times enhance compliance and improve the quality and consistency of regulatory documentation.

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 Alcons 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!

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Compensation and Benefits

Alcons Total Rewards programs are designed to align incentives with business objectives support our values and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay with shortterm and longterm 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 wellbeing 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.

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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 and let us know the nature of your request and your contact information.