Senior Manager, Regulatory CMC
Senior Manager, Regulatory CMC
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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. As a Senior Manager Regulatory CMC supporting the Regulatory Affairs Team in Fort Worth TX a typical day will include:
Develops and implements global chemistry manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics pharmaceuticals and devices.
Prepares and directs the development of CMC submissions including initial market registrations progress reports supplements amendments and/or periodic experience reports.
Interacts and negotiates with regulatory agencies in order to expedite approval of pending registration and answer any questions.
Participates in the identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes leads development of company policy and positions on draft regulations and guidance.
Develop and implement global CMC regulatory strategies throughout the lifecycle of biologics pharmaceuticals and devices.
Prepare and direct CMC submissions including initial market registrations progress reports supplements amendments and periodic experience reports.
Represents the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions.
Identify risk areas develop alternative courses of action and assess the impact of new regulations to implement necessary changes.
Lead the development of company policy and positions on draft regulations and guidance.
Demonstrate strategic thinking advanced regulatory knowledge excellent communication leadership 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.
WHAT YOULL BRING TO ALCON:
Bachelors Degree or Equivalent years of directly related experience (or high school15 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
Location: Onsite
Travel: 5%
Relocation: No
Sponsorship Assistance: No
Preferred
Global regulatory CMC strategy development experience.
Technical writing skills with experience in major regulatory submissions (e.g. NDA/MAA/IND)
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 Alcons 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 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.
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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY
Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation 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 Manager
Employment Type
Full-Time
