Director of Regulatory Operations & Submissions

Regulatory Jobs

Fort Worth (TX)

In loco

USD 200.000 - 259.000

Tempo pieno

3 giorni fa

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Descrizione del lavoro

Alcon is seeking a Director of Regulatory Operations to lead regulatory submissions and product strategy within the Quality & Regulatory Affairs function. The role emphasizes directing dossier preparation, licensing, and labeling, while driving continuous improvement of Veeva RIM and cross-functional collaboration.

The position requires a Bachelor’s degree or equivalent, 10 years of relevant experience, and 6 years of demonstrated leadership.

Competenze

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

Mansioni

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 SOPs in line with process improvements
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