Job Summary:The
Sr. Regulatory Operations Specialist is responsible for planning, preparing, publishing, and managing regulatory submissions to global health authorities, with a focus on U.S. FDA electronic submissions (INDs, BLAs, supplements, annual reports, etc.). This individual will play a key role in supporting submission readiness, document management, and system compliance through the use of electronic Regulatory Information Management Systems (RIMS).
Reporting to: Associate Director, Regulatory Affairs
Location: Johnson City, TN - 4 days/week onsite
Responsibilities/Essential Duties:- Provide detailed review of data and reports that will be incorporated into regulatory submissions to ensure scientific accuracy and clarity of presentation.
- Prepare, compile, and review regulatory submissions to ensure compliance with Health Authority regulations and guidelines, company policies/procedures.
- Manage routine submissions such as safety reports, investigator updates, and IND Annual Reports.
- Maintain and oversee submission workflows within Veeva Vault RIM (or equivalent RIMS).
- Create timelines and submission plans, and track deliverables to ensure on-time submissions/approvals.
- Ensure submissions meet all applicable regulatory, technical, and formatting requirements (e.g. FDA eCTD specifications, ICH M4).
- Ensure proper document control, metadata tagging, and archival of submission components.
- Conduct quality control (QC) checks for accuracy, technical compliance, and completeness prior to submission.
- Interface with Regulatory partners and internal cross-functional teams.
Basic Qualifications: - Bachelor's degree & 2-3 years' directly related experience.
Preferred Qualifications:- Bachelor's degree.
- 2-3 years' experience in Regulatory Operations within the pharmaceutical industry.
- Experience with Veeva Vault RIM.
- Proven experience preparing and submitting eCTD submissions (INDs, NDAs, BLAs, amendments, supplements, and annual reports) to FDA and/or global agencies.
- Strong understanding of ICH, FDA, and regional electronic submission standards and lifecycle management.
- Proficient in Microsoft Word, Adobe, Excel, and PowerPoint.
- Excellent written and verbal communication skills.
- Detail-oriented with well-developed organizational skills.
- Able to work efficiently and independently.
What Revance invests in you:- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
