Bachelor's Degree or equivalent experience in a related field
Fluent in English (reading, writing, and communication)
2 years of relevant experience in regulatory affairs or lifecycle management
Experience with SAP ERP systems preferred
Strong analytical and problem-solving skills
Responsibilities
Perform specialized tasks and conduct independent research for lifecycle management
Assist in preparing and submitting regulatory documents
Support cross-functional teams in lifecycle management requirements
Provide product portfolio analyses and reports for decision-making
Lead implementation of New Product Launch Requests and change projects
Manage end-to-end activities related to packaging component changes
Coordinate data setup activities to support product launches
Benefits
Robust health and life insurance package
Retirement plan options
Flexible time off for exempt associates
Paid time off for hourly associates
Focused growth and development opportunities
Full Job Description
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 Experience
Location: Onsite -Fort Worth-ASPEX
Schedule: 1st Shift: Monday - Friday
Travel Requirements: 0-10%
Sponsorship & Relocation: Not Available
PREFERRED EXPERIENCE:
Experience with SAP ERP Systems
Understanding of manufacturing operations, supply chain processes, and material lifecycle management
Proficiency utilizing BI reporting tools for data analysis, validation, and reporting solutions
Experience with change control systems and documentation practices
Excellent project management and communication skills
Detail-oriented with strong analytical and problem-solving abilities
SAP knowledge
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 Alcon's 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!
Alcon Careers
See your impact at alcon.com.careers
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
