Remote Regulatory Affairs Manager - Global Submissions

Revance Therapeutics, Inc.; 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

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.