Sr. Regulatory Operations Specialist

Revance•Johnson City, TN

4d•Onsite

About The Position

The Sr. Regulatory Operations Specialist plans, prepares, publishes, and manages regulatory submissions to global health authorities, with a focus on U.S. FDA electronic submissions, including INDs, BLAs, supplements, and annual reports. The role supports submission readiness, document management, and system compliance using electronic Regulatory Information Management Systems (RIMS). It reports to the Associate Director, Regulatory Affairs and is based in Johnson City, Tennessee, with four days per week onsite.

Requirements

Bachelor’s degree.
Two to three years of directly related experience.

Nice To Haves

Two to three years of experience in Regulatory Operations within the pharmaceutical industry.
Experience with Veeva Vault RIM.
Proven experience preparing and submitting eCTD submissions, including INDs, NDAs, BLAs, amendments, supplements, and annual reports, to the FDA and/or global agencies.
Strong understanding of ICH, FDA, and regional electronic submission standards and lifecycle management.
Proficiency in Microsoft Word, Adobe, Excel, and PowerPoint.
Excellent written and verbal communication skills.
Detail-oriented with well-developed organizational skills.
Ability to work efficiently and independently.

Responsibilities

Review data and reports in detail to ensure scientific accuracy and clarity of presentation in regulatory submissions.
Prepare, compile, and review regulatory submissions for compliance with Health Authority regulations and guidelines, and company policies and procedures.
Manage routine submissions, including safety reports, investigator updates, and IND Annual Reports.
Maintain and oversee submission workflows within Veeva Vault RIM or an equivalent RIMS.
Create timelines and submission plans, and track deliverables to support on-time submissions and approvals.
Ensure submissions meet applicable regulatory, technical, and formatting requirements, including FDA eCTD specifications and ICH M4.
Ensure appropriate document control, metadata tagging, and archival of submission components.
Conduct quality control checks for accuracy, technical compliance, and completeness before submission.
Interface with Regulatory partners and internal cross-functional teams.