Director, Regulatory Affairs Operations

U341 Alcon Research, LLC. Company; Fort Worth (TX); On-site; USD 200,000 - 259,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Alcon is seeking a Director, Regulatory Operations (Management Path) to direct product and process registration submissions and provide strategic direction to teams. The role emphasizes leading multidisciplinary groups, building relationships with regulatory bodies, and driving SOP-driven compliance across global regulatory activities.

The position sits onsite in Fort Worth, TX, requires 10+ years in regulatory roles and 6+ years of leadership, and offers a competitive annual salary with a

Qualifications

• Bachelor's Degree or equivalent years of directly related experience.
• Fluently read, write, 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, submission publishing, licensing, and labeling.
• Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and 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 SOPs accordingly.
• Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions.
• Ensure timely and accurate submission of regulatory documents.

Skills

Leadership

Regulatory affairs leadership

Cross-functional collaboration

Submission management

GxP compliance

Education

Bachelor's Degree

Tools

Veeva RIM Suite

Job description

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 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.

• 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
• 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 See your impact at alcon.com.careers

Alcon is an Equal Opportunity Employer and participates in E-Verify.

Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, 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 [e-mail] and let us know the nature of your request and your contact information.

Alcon, which was founded in 1945, sells its products in 180 countries worldwide. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well‑known Opti-Free line of contact lens solutions and related products.

Pay Range $199,750.00 - $258,500.00 Pay Frequency Annual

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.