Senior Associate I, Regulatory Affairs Strategy
Senior Associate I, Regulatory Affairs Strategy
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$ 85200 - 127800
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. We foster an inclusive culture and are looking for diverse dedicated people to join Alcon. As a Senior Associate I Regulatory Strategy joining our Regulatory Affairs team in Lake Forest CA you are responsible for providing support in ensuring compliance with all FDA and other U.S. and global regulatory requirements. This position supports internal and global customers to meet corporate submission and registration objectives for timely approval.
- Work with global partners and support worldwide registrations efforts.
- Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives.
- Manages requests from regions and countries provides responses and requested documentation (CFGs FSC certifications Letter of Authorization etc.) in a timely manner.
- Prepares supporting documentation and arrange for legalizations as required by country regulations.
- Support communications with US and international affiliates and regulatory personnel.
- Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
- Provides high quality regulatory support for assigned products/projects.
- Develops documents that are clear concise and complete to facilitate and maintain registration renewal tenders and licenses.
- Prepare consolidate response and followup on change assessments for global regulatory strategies.
- Review and approve labeling to ensure accuracy of content.
- Maintain a current knowledge of global medical device regulations pertaining to the distribution of products which include facility registration and device listing.
- Maintain documentation and a historical record for regulatory submissions.
- Notarize regulatory registration documents as necessary. Willing to obtain notary license in California.
WHAT YOULL BRING TO ALCON:
Key Requirements/Minimum Qualifications:
- Bachelors 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
How you can thrive at Alcon:
- Benefit from working in a highly collaborative environment.
- Join Alcons 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 and much more!
- Travel Requirements: 10%
- Relocation assistance: No
- Sponsorship available: No
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 Contingent Worker
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
$85200.00 $127800.00Pay 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:
Senior IC
Employment Type
Full-Time
