Sr Manager Regulatory Affairs Strategy - Global - Pharma
Sr Manager Regulatory Affairs Strategy - Global - Pharma
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Job Description
Job Title: Sr. Manager Regulatory Affairs Strategy Global Pharma
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 are currently hiring a Sr. Manager Regulatory Affairs Strategy Global Pharma for Alcon based out of New Jersey. We are looking for dynamic inspiring inclusive team members who collaborate with others knowing that diverse talent skills and perspectives lead to better outcomes. Alcon manufacturing is a fast paced highenergy environment so naturally we are looking for someone who is a relationship builder an excellent analytical thinker intuitive to business needs and someone who can effectively communicate in challenging situations creating winwin scenarios. Above all we are looking for someone with a passion for customer service and helping Alcon in our mission to help everyone see brilliantly!
A Day in the Life:
As a Sr. Manager Regulatory Affairs Strategy Global Pharma you are responsible for unleashing the full potential of our people and culture while simultaneously achieving timely and costeffective manufacturing of highquality medical devices.
Global Regulatory Affairs 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 chemistry manufacturing control (CMC)
- Ensuring preclinical and clinical trial designs meet regulatory requirements Ensuring rapid and timely approval of new biologics/biotechnology products and continued approved status of marketed or 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 new and biologic/biotechnology products and marketed products notices.
Key Requirements/Minimum Qualifications:
- Bachelors Degree or Equivalent years of directly related experience (or high school 15 yrs; Assoc.11 yrs; M.S.4 yrs; PhD3 yrs)
- The ability to fluently read write understand and communicate in English
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
Work hours: MF 8am 5pm
Travel Requirements: Up to 10
Relocation assistance: none
Sponsorship available: None
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
See your impact at 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
Alcon 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
