Sr. Associate, Lifecycle Management

Alcon; Fort Worth (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Alcon in Fort Worth, TX is seeking a Sr. Associate, Lifecycle Management (Professional Path) to manage regulatory affairs activities across the product lifecycle, ensuring compliance with global and local regulations and maintaining rigorous quality control.

You will partner with Manufacturing, Supply Chain, Quality, and Finance to support regulatory submissions, packaging changes, and lifecycle projects, while delivering accurate documentation in SAP, TrackWise, and other systems.

Qualifications

• Bachelor’s degree or equivalent experience.
• 2 years of relevant regulatory experience.
• English reading/writing fluency required.

Responsibilities

• Manage regulatory lifecycle activities and submissions.
• Coordinate change controls and documentation in systems.
• Collaborate with Manufacturing, Supply Chain and Quality.
• Provide portfolio analyses for management committees.
• Lead NPL/EPCR/Divestment related projects as assigned.

Skills

SAP ERP Systems

BI reporting tools

Change control systems

Cross-functional collaboration

Education

Bachelor's Degree

Tools

TrackWise

Job description

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 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

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 [e-mail] and let us know the nature of your request and your contact information. At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.