Director, Regulatory Affairs Operations

Alcon • Fort Worth, TX

7d • Onsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 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 Alcon's 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.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership

Responsibilities

• 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.

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Director