Director, Regulatory Affairs Operations

Alcon Research•Fort Worth, TX

5d•$199,750 - $258,500•Onsite

About The Position

The Director, Regulatory Operations (Management Path) is part of Alcon’s Quality & Regulatory Affairs function and is responsible for directing product and process registration submissions and providing strategic product direction to teams. The role supports medical device products across the Surgical and Vision Care Franchises, builds relationships with regulatory agencies to help expedite approvals and address inquiries, and promotes compliant, timely, and accurate submissions. The Director leads and mentors teams across dossier preparation, Clinical Trial Disclosure, submission management and publishing, licensing, and labeling. The role drives continuous improvement and rollout of the Veeva RIM Suite, develops process documentation and job aids, provides user requirements and configuration recommendations, and updates associated SOPs. The Director also oversees requests for documentation supporting marketing applications, makes decisions affecting departmental performance, and develops strategies aligned with company goals. The position is onsite in Fort Worth, Texas, on the first shift, Monday through Friday, with 0–10% travel. Relocation is available. Alcon lists an annual pay range of $199,750 to $258,500. The company describes benefits that include health, life, retirement, flexible time off for exempt associates, and PTO for hourly associates, as well as other benefits.

Requirements

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

Responsibilities

Direct product and process registration submissions and provide strategic product direction to teams.
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 SOPs in line with process improvements and auto releases.
Foster 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 for 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, ensure rigorous quality control, complete required training, and contribute to continuous improvement and organizational compliance.