Manager, Regulatory Affairs

Revance; Tennessee; Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Flexible PTO

Healthcare benefits

Job summary

Revance Therapeutics, Inc. is seeking a Regulatory Affairs Manager to lead activities across non-clinical, clinical, CMC, and promotional domains for investigational and marketed products.

This hands-on role partners with internal and external stakeholders to ensure regulatory compliance throughout the product lifecycle. The ideal candidate will manage IND/CTA, BLA/MAA submissions, and global interactions, with a focus on promotional material review and FDA OPDP requirements.

Qualifications

• Bachelor's degree and 5+ years of direct regulatory affairs experience.
• Experience in promotional material review and FDA OPDP knowledge.
• Experience with regulatory submissions across IND/CTA, BLA/MAA and eCTD format.

Responsibilities

• Manage advertising and promotional submissions (2253s) for BLA.
• Provide cross-functional regulatory plans translating requirements into actionable plans.
• Prepare, review, and submit regulatory documents for IND/CTA, BLA/MAA across modules.
• Collaborate on submission content across functions for INDs/CTAs/BLAs/NDAs.
• Ensure timely preparation of organized, scientifically valid applications.
• Interact with regulatory agencies on defined matters.
• Implement regulatory documentation infrastructure for submissions.
• Mentor and train direct reports.
• Travel up to 15%.

Skills

Promotional material review

FDA OPDP knowledge

Education

Bachelor's degree

Chemistry/Biology/Pharmaceutical Science degree

Tools

eCTD submission experience

Job description

Job Summary

The Regulatory Affairs Manager is responsible for managing Regulatory Affairs activities across all functional areas - non-clinical, clinical, CMC, and advertising/promotional (Ad Promo) for both investigational and marketed products. This is a cross-functional role that partners with internal and external stakeholders to ensure strategic alignment and regulatory compliance throughout the product life cycle.

The ideal candidate will have a solid understanding of regulatory requirements across development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands‑on role in a fast‑paced environment that requires flexibility, attention to detail, and strong communication skills.

Reporting to: Associate Director, Regulatory Affairs
Location: Remote - travel <15%

Responsibilities/Essential Duties

• Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA representative on the Promotional Review Committee.
• Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross‑functional teams.
• Manage the preparation, review, and submission of regulatory documents across all modules (non‑clinical, clinical and CMC) for IND/CTA, BLA/MAA, and other global submissions documents; may manage e‑submission vendors.
• Collaborate on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, and annual reports).
• Ensure timely preparation of organized and scientifically valid applications.
• Interact with regulatory agencies on defined matters.
• Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
• Mentor, guide and train direct reports.
• May be required to travel up to 15%.

Basic Qualifications

• Bachelor's degree & 5+ years' directly related experience.
• Direct experience in promotional material review and knowledge of FDA OPDP requirements.

Preferred Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field.
• Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics.
• Regulatory Affairs certification or equivalent training.
• Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.
• Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements.
• Experience directly interfacing with regulatory authorities.

Company Summary

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.