Director, Regulatory Affairs Operations

The Director, Regulatory 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.

In this role, a typical day will include:

• Lead and mentor teams in dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling
• 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
• The Director, Regulatory Affairs Operations will support the medical device portfolio of products across the Surgical and Vision Care Franchises

YOU'LL BRING TO ALCON:

• 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
• Location: Onsite- Fort Worth, TX
• Schedule: 1st Shift: Monday - Friday
• Travel Requirements: 0-10%
• Relocation: Yes

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Alcon Careers

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Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long-term value. Our compensation approach includes a combination of fixed and variable pay, with short-term and long-term incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and well-being, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range
$199,750.00 - $258,500.00

Pay Frequency
Annual