At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 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 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 Sr. Associate, Lifecycle Management (Professional Path) is primarily responsible for managing regulatory affairs activities related to product lifecycle management, ensuring compliance with local and international regulations. You will work closely with cross-functional teams to support regulatory submissions, product changes, and maintain regulatory approvals throughout the product lifecycle.
In this role, a typical day will include:
Perform specialized tasks and conduct independent research to optimize lifecycle management outcomes, contributing to project goals with advanced skills
Assist in the preparation and submission of regulatory documents, ensuring compliance with relevant regulations
Support cross-functional teams in meeting lifecycle management requirements and work with various departments to impact the efficiency and success of product lifecycle management and regulatory submissions
Provide product portfolio analyses and reports to management committees for decision-making support
Make decisions within the scope of assigned tasks, requiring advanced knowledge, analytical skills, and self-direction
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintain accurate and complete documentation, ensuring rigorous quality control
Complete all required training and contribute to the overall compliance of the organization, committing to continuous improvement in operations
Lead the implementation of New Product Launch Requests (NPL) / Existing Product Change Request (EPCR) / Divestment / Rationalization projects as assigned
Manage the end-to-end activities related to packaging component changes, including artwork updates, material changes, and specification revisions
Analyze, coordinate and complete new material master setup and change requests in Alcon ERP systems to support day to day business operations
Coordinate data setup activities like costing, pricing, source list, PIRs, material data extension approvals to support product launches in manufacturing
Work closely with other business teams like Manufacturing, Supply Chain, Finance, Quality, and Sales, to address and resolve master data issues in a timely manner
Coordinate and manage change control records from initiation through closure
Monitor progress of open change controls and drive timely completion of action items
Escalate overdue actions and implementation delays to management as necessary
Maintain accurate documentation and change control records in relevant systems (e.g., Ensure, SAP, TrackWise)
Collaborate cross-functionally with Global Lifecycle Management, Quality, Procurement, Manufacturing, Engineering, and Supply Chain to ensure alignment and timely execution
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintain accurate and complete documentation, ensuring rigorous quality control
Complete all required training and contribute to the overall compliance of the organization, committing to continuous improvement in operations
WHAT YOU’LL BRING TO ALCON:
Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc. +6 yrs; M.S. +0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant…