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2 Director, Regulatory Operations, Labeling Jobs in Fort Worth, TX

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U341 Alcon Research, LLC. Company
Fort Worth, TX | Full Time
$156k-207k (estimate)
2 Months Ago
Alcon
Fort Worth, TX | Full Time
$175k-233k (estimate)
1 Week Ago
Director, Regulatory Operations, Labeling
$156k-207k (estimate)
Full Time 2 Months Ago
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U341 Alcon Research, LLC. Company is Hiring a Director, Regulatory Operations, Labeling Near Fort Worth, TX

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 Director of Regulatory Operations, Labeling supporting US Dev Global Regulatory Affairs Operations, you will be trusted to drive Global Regulatory strategy to facilitate market success and is responsible for ensuring close collaboration with key collaborators at Fort Worth, TX. In this role, a typical day will include: Direct submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports Stay ahead of changing global labeling requirements and communicate those changes within GRA and to cross-functional colleagues. Responsible for Corporate RA SOPs regarding labeling and sets boundaries and/or coordinate with RA affiliates on local labeling procedures. Own RA Labeling process and current project work under project Clear. Represent RA in the Labeling Change Review Board. Be the counterpart to the GSC Labeling Head and be involved with cross-functional decisions and critical issue pathways. Share responsibility with GRA strategists for decision-making on bundling and/or deferring proposed label changes, and/or deviations to label requirements. Coordinate and lead close partnership with the GRA team and support a broad portfolio for Labeling. Anticipate and provide assessments of changing regulations and mentorship and identify any required changes to internal Labeling policies and processes as the Labeling RA SME. Develop and lead global Labeling regulatory strategies to improve the value of the portfolio. WHAT YOU'LL BRING TO ALCON: Bachelor’s Degree or Equivalent years of directly related experience (or high school 18 yrs.; Assoc. 14 yrs.; M.S. 7 yrs.; PhD 6 yrs.) The ability to fluently read, write, understand and communicate in English 10 Years of Relevant Experience 6 Years of Demonstrated Leadership Work hours: M-F Travel Requirements: up to 20% Relocation assistance: Yes Sponsorship available: No PREFERRED QUALIFICATIONS/SKILLS/EXPEREINCE Background in Regulatory Affairs and Labeling Ability to excel in a matrixed environment and influence internal and external partners to achieve desired business outcomes Strong writing skills and editing in the form of high-quality regulatory submission documents HOW YOU CAN THRIVE AT ALCON: 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 robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more! 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 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 alcon.recruitment@alcon.com 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. 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

Job Summary

JOB TYPE

Full Time

SALARY

$156k-207k (estimate)

POST DATE

02/29/2024

EXPIRATION DATE

04/22/2024

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