Senior Director, Regulatory Affairs CMC
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Job Location:
Fort Worth, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us
This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see brilliantly.
The Sr. Director Chemistry Manufacturing & Control (CMC) (Management Path) is primarily responsible for shaping and leading the execution of global CMC regulatory strategies for biologics pharmaceuticals and combination products across Alcons global portfolio. You will lead CMC submissions strategically engage with health authorities and guide the team in assessing regulatory challenges. Youll also proactively identify risks develop solutions and guide company policies on regulations.
Specifics include:
- Lead development and implementation of global CMC regulatory practices and strategies to support product development throughout the lifecycle of biologics pharmaceuticals and combination products maintaining regulatory compliance to drive competitive advantage
- Design and direct the development of Regulatory Affairs CMC team and capabilities to streamline regulatory support for CMC related projects and activities
- Oversee all of Alcons global CMC submissions including initial market registrations progress reports supplements amendments and annual reports
- Represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions
- Proactively identify risk areas develop alternative courses of action and assess the impact of new regulations to prepare the team 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
- Oversee and serve as primary decision-maker for CMC regulatory assessment and acquisition/integration strategy for business development and licensing activities
- Attract retain and develop Regulatory Affairs CMC talent
- 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
- The ability to fluently read write understand and communicate in English
- 12 Years of Relevant Experience
- 8 Years of Demonstrated Leadership
- Travel: Minimal
- Work Location: Onsite Fort Worth TX (This role may be based at other Alcon locations subject to business needs)
- Relocation Assistance/Sponsorship: None
How you can thrive at Alcon:
- Work together with colleagues to share standard methodologies and discoveries as work progresses.
- Discover your career in a fresh way through specific growth and development possibilities.
- 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 for exempt associates PTO for hourly associates and much more!
Alcon Careers
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
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:
Exec
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
