Sr. Regulatory Operations Specialist
Revance
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).
Job description
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).
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.
Requirements
- Bachelor's degree
- 2-3 years' directly related experience
- 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
Benefits
- Competitive Compensation
- Annual Performance Bonus
- Flexible PTO
- Holidays
- Parental Leave
- Healthcare Benefits
- HSA Match
- 401(k) Match
- Employer-Paid Life Insurance
- Employer-Paid Disability Insurance
- Pet Insurance
- Wellness Discounts
Company overview
Revance is a leading biotechnology company that specializes in developing innovative aesthetic, skincare, and therapeutic products through science-powered innovation. Founded in 1999 and headquartered in Nashville, Tennessee, the company has grown into a fully-integrated global organization with operations spanning over 60 countries. Revance is best known for its groundbreaking DAXXIFY® (daxibotulinumtoxinA-lanm), a peptide-stabilized botulinum toxin that represents the first true innovation in neuromodulator formulation in over 20 years. The company's diverse portfolio includes aesthetic injectables, consumer skincare brands like StriVectin and Blue Lizard sunscreen, and therapeutic treatments for conditions such as cervical dystonia. With a team of 1,001-5,000 employees, Revance combines deep scientific expertise with commercial excellence to deliver differentiated products that address unmet needs in health, beauty, and wellness across generations.