Remote Regulatory Submissions Lead: FDA eCTD Expert

Revance Therapeutics, Inc.; Johnson City (TN); Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Revance Therapeutics, Inc. is seeking a Sr. Regulatory Operations Specialist to plan, prepare, publish, and manage regulatory submissions to global health authorities, with a focus on FDA electronic submissions (INDs, BLAs, supplements).

You will support submission readiness, document control, and system compliance using electronic RIMS such as Veeva Vault. Reporting to the Associate Director of Regulatory Affairs, this role requires meticulous attention to detail, strong communication, and the

Qualifikationen

• Bachelor's degree and 2–3 years of experience in regulatory operations.
• Experience with FDA eCTD submissions (INDs, NDAs, BLAs, amendments, supplements, annual reports).
• Strong knowledge of ICH, FDA, and regional electronic submission standards and lifecycle management.
• Proficient in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Aufgaben

• Provide detailed review of data and reports for regulatory submissions.
• Prepare and review regulatory submissions to ensure compliance with Health Authority regulations.
• Manage routine submissions such as safety reports and annual reports.
• Maintain and oversee submission workflows within Veeva Vault RIM (or equivalent).
• Create timelines and submission plans and track deliverables for on‑time submissions.
• Interface with Regulatory partners and cross‑functional teams.

Kenntnisse

Regulatory submissions proficiency

Attention to detail

Communication skills

Independent work

Ausbildung

Bachelor's degree

Tools

Veeva Vault RIM

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Jobbeschreibung

Revance Therapeutics, Inc. is seeking a Sr. Regulatory Operations Specialist to plan, prepare, publish, and manage regulatory submissions to global health authorities, with a focus on FDA electronic submissions (INDs, BLAs, supplements).

You will support submission readiness, document control, and system compliance using electronic RIMS such as Veeva Vault. Reporting to the Associate Director of Regulatory Affairs, this role requires meticulous attention to detail, strong communication, and the