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Senior Regulatory Operations Specialist

Nashville, TN or Remote

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: VP, Regulatory Affairs
Location: Nashville, TN, Johnson City, TN  or *Remote:
Salary Range: *$85,000-$90,000 + annual incentive bonus 

*remote candidates must be located in Eastern or Central time zones

** the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.

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 or equivalent experience.
  • 2-3 year of experience in Regulatory Operations within the pharmaceutical industry.
  • Experience with Veeva Vault RIM is preferred.
  • 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.


Preferred Qualifications:

  • Proficient in MS Word, Adobe, Excel, and PowerPoint
  • Must possess excellent written and verbal communication skills
  • Must be detail oriented with well-developed organizational skills
  • Must be able to work efficiently and independently


Company Summary:

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
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What Revance invests in you:

  • Competitive Compensation including base salary and annual performance bonus.
  • Paid time off, company holidays, and floating holidays that can be used whenever you choose.
  • Generous healthcare benefits, Employer HSA match, 401k match, 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.

 

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