Manager I Regulatory Affairs Strategy - Global
Manager I Regulatory Affairs Strategy - Global
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$ 108880 - 163320
1 Vacancy
Job Description
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 youll 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.
At Alcon the Manager I Regulatory Affairs Strategy Global is responsible for the regulatory lifecycle management aspects of products out of the Lake Forest and Fort Worth design centers including: change analyses submissions project team support and any other necessary duties.
Product Regulatory Affairs (Life Sciences & Agriculture) work includes:
- Directing submission development of product registration progress reports supplements amendments and/or periodic experience reports
- Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies
- Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions
- Serving as a regulatory liaison on the project team throughout the product lifecycle
- Participating in one or all of the following activities: development of product plan regulatory strategy risk management implementation plan
- Ensuring preclinical and clinical trial designs meet regulatory requirements
- Ensuring rapid and timely approval of medical devices and continued approved status of medical devices
- Serving as regulatory representative to marketing or research project teams and government regulatory agencies
- Providing advice to development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations
- Coordinating reviewing and potentially preparing reports for submission In some organizations may coordinate and maintain reporting schedules for medical devices and marketed products notices.
WHAT YOULL BRING TO ALCON:
- Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)
- The ability to fluently read write understand and communicate in English
- 5 Years of Relevant Experience
Preferred Experience:
- Regulatory Experience with Medical Devices
HOW YOU CAN THRIVE AT ALCON:
- Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
- Collaborate with teammates to share standard processes and findings as work evolves!
- See your career like never before with focused growth and development opportunities!
- Alcon provides robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!
Alcon Careers
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Total Rewards
Alcons Total Rewards programs are designed to align to incentives with business goals encourage the right values and behaviors and deliver longterm value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes shortterm incentives and longterm 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 wellbeing and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here
Pay Range
$108880.00 $163320.00Pay Frequency
AnnualAlcon is an Equal Opportunity Employer and participates in EVerify. 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 and let us know the nature of your request and your contact information.
Required Experience:
Exec
Employment Type
Full-Time
