Manager, Regulatory CMC

Alcon Research • Fort Worth, TX

1d • $105,000 - $175,000 • Onsite

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Manager, Regulatory Affairs CMC supporting the Global Regulatory Affairs Team in Fort Worth, TX or Lake Forest, CA, a typical day will include: Implements global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. Contributes to the development of CMC submissions, including initial market registrations, progress reports, supplements, amendments, and periodic experience reports. With guidance, may represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions. Participates in identification of risk areas, develop alternative courses of action, and assess the impact of new regulations to implement necessary changes. Contributes to the development of company policy and positions on draft regulations and guidance. Demonstrate credible regulatory knowledge, excellent communication, and problem-solving abilities. Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training. Meet individual job requirements and contribute to overall organizational compliance while committing to continuous improvement and compliance with regulatory requirements. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations. WHAT YOU’LL BRING TO ALCON: 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 Worksite location: Onsite Travel: 5% Relocation: No Sponsorship Assistance: No HOW YOU CAN THRIVE: Collaborate with teammates to share standard processes and findings 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 a robust benefits package including health, life, retirement, flexible time off 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. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here Pay Range $105,000.00 - $175,000.00 Pay Frequency Annual 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 [email protected] and let us know the nature of your request and your contact information.

Requirements

• 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

Responsibilities

• Implements global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices.
• Contributes to the development of CMC submissions, including initial market registrations, progress reports, supplements, amendments, and periodic experience reports.
• With guidance, may represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions.
• Participates in identification of risk areas, develop alternative courses of action, and assess the impact of new regulations to implement necessary changes.
• Contributes to the development of company policy and positions on draft regulations and guidance.
• Demonstrate credible regulatory knowledge, excellent communication, and problem-solving abilities.
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training.
• Meet individual job requirements and contribute to overall organizational compliance while committing to continuous improvement and compliance with regulatory requirements.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
• Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
• Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.
• Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.
• The first layer of our rewards program is compensation.
• We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.
• Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager