Director, Regulatory Affairs Operations

Alcon • Fort Worth, TX

16h • $199,750 - $258,500 • Onsite

About The Position

The Director, Regulatory Operations (Management Path) is responsible for directing product and process registration submissions and providing strategic product direction to teams. The role builds effective relationships with regulatory agencies to expedite approvals and address inquiries. It supports Alcon’s medical device portfolio across the Surgical and Vision Care Franchises.

The Director leads and mentors teams responsible for dossier preparation, Clinical Trial Disclosure, submission management and publishing, licensing, and labeling. The role maintains and improves the Veeva RIM Suite, supports its rollout to cross-functional teams, develops job aids for document approval processes and submission tracking, and provides user requirements and recommendations for Veeva releases and configurations. It also updates related Standard Operating Procedures as processes and software releases evolve.

The position fosters relationships with regulatory staff and cross-functional teams to prioritize compliant submissions, oversees a product support request tool, and ensures requests for documentation supporting marketing applications are fulfilled on time. The Director develops and implements strategies aligned with company goals, makes decisions affecting departmental performance, and ensures accurate and timely regulatory submissions. The role requires adherence to GxP regulations, SOPs, documentation and quality-control standards, required training, and continuous improvement.

Requirements

• Bachelor’s degree or equivalent years of directly related experience; stated alternatives include high school plus 18 years, an associate degree plus 14 years, a master’s degree plus 7 years, or a Ph.D. plus 6 years.
• 10 years of relevant experience.
• 6 years of demonstrated leadership.
• Ability to fluently read, write, understand, and communicate in English.

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 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 SOPs in line with process improvements and releases.
• Build relationships with regulatory staff and cross-functional teams to prioritize compliant submissions.
• Oversee the product support request tool and ensure documentation requests supporting marketing applications are fulfilled in a timely manner.
• Develop and implement strategies to ensure departmental success and alignment with company goals.
• Make key decisions that affect department performance and success.
• Ensure regulatory documents are submitted accurately and on time.
• Follow GxP regulations and SOPs, maintain accurate and complete documentation, and ensure rigorous quality control.
• Complete required training and contribute to organizational compliance through continuous improvement and adherence to regulatory requirements.

Benefits

• Health benefits
• Life benefits
• Retirement benefits
• Flexible time off for exempt associates
• PTO for hourly associates
• Short-term and long-term incentive opportunities for eligible roles
• Programs supporting health and well-being, financial security, and retirement planning
• Focused growth and development opportunities

What This Job Offers

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