Director, Regulatory Affairs Operations
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Job Location:
Fort Worth, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
16 days 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 Director Regulatory Affairs Operations (Management Path) is primarily responsible for directing product/process registration submissions and providing strategic product direction to teams. You will build effective relationships with regulatory agencies to expedite approvals and address inquiries. Specifics include:
- Lead and mentor teams in dossier preparation Clinical Trial Disclosure submission management and submission publishing.
- Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and facilitate its rollout to cross-functional teams.
- Create job aids detailing document approval processes workflows and submission tracking.
- Provide user requirements and recommendations for Veeva auto releases and configurations and update associated Standard Operating Procedures (SOPs) in line with process improvements and auto releases.
- Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions.
- Maintain oversight of the product support request tool and ensure all requests for documentation in support of marketing applications are fulfilled in a timely manner.
- Develop and implement strategies to ensure departmental success and alignment with company goals.
- Make key decisions impacting department performance and success.
- Ensure timely and accurate submission of regulatory documents.
- Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation and ensuring rigorous quality control.
- Complete all required training and contribute to the overall compliance of the organization by committing to continuous improvement and adherence to regulatory requirements. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
- The Director Regulatory Affairs Operations will support the medical device portfolio of products across the Surgical and Vision Care Franchises.
What Youll Bring to Alcon
- Bachelors Degree or Equivalent years of directly related experience (or high school 18 yrs; Assoc.14 yrs; M.S.7 yrs; PhD6 yrs)
- The ability to fluently read write understand and communicate in English
- 10 Years of Relevant Experience
- 6 Years of Demonstrated Leadership
- Travel: 10-20% Domestic
- Work Location: Onsite Fort Worth TX (This role may be based at other Alcon locations subject to business needs)
- Relocation: Yes
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:
Director
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.
