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 such as INDs, BLAs, supplements, and annual reports. The role supports submission readiness, document management, and system compliance using electronic Regulatory Information Management Systems (RIMS). This position reports to the Associate Director, Regulatory Affairs and is based in Johnson City, Tennessee, with four days per week onsite. The specialist reviews data and reports for scientific accuracy and clarity; prepares and reviews submissions for compliance with applicable regulations, guidelines, and company procedures; and manages routine submissions. The role also oversees submission workflows, timelines, deliverables, document control, metadata tagging, archival, and quality checks. The specialist works with Regulatory partners and internal cross-functional teams.

Requirements

Bachelor’s degree.
Two to three years of directly related experience.
Excellent written and verbal communication skills.
Detail-oriented with well-developed organizational skills.
Able to work efficiently and independently.

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.

Responsibilities

Review data and reports for scientific accuracy and clarity of presentation before incorporation into 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 regulatory, technical, and formatting requirements, including FDA eCTD specifications and ICH M4.
Ensure proper 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.