Sr. Regulatory Operations Specialist

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.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings.Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company’s vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance’s award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.

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!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.