Remote Regulatory Affairs Manager – Global Submissions

Revance Therapeutics, Inc.; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Job summary

Revance Therapeutics, Inc. is seeking a Regulatory Affairs Manager to oversee regulatory activities across non-clinical, clinical, CMC, and Ad Promo for investigational and marketed products.

You will collaborate cross-functionally to ensure compliance and strategic alignment throughout the product lifecycle in a fast-paced environment. The ideal candidate has deep experience with INDs, CTAs, BLAs, global submissions, and promotional material reviews, with strong communication skills and the

Qualifications

• Bachelor's degree and 5+ years of directly related experience.
• Direct experience in promotional material review and FDA OPDP requirements.
• Experience with INDs/CTAs and BLA/MAA submissions.
• Knowledge of US/EU/Health Canada/Australia/ICH regulatory requirements.
• Experience interfacing with regulatory authorities.

Responsibilities

• Manage advertising and promotional submissions (2253s) for BLA and act as RA on the Promotional Review Committee.
• Translate local, regional, and international regulatory requirements into workable cross-functional plans.
• Prepare, review, and submit regulatory documents across non-clinical, clinical and CMC for IND/CTA, BLA/MAA.
• Collaborate on submission content with authors across functions to ensure clarity and compliance.
• Ensure timely preparation of organized, scientifically valid applications.
• Interact with regulatory agencies on defined matters.
• Execute regulatory documentation infrastructure, including paper and electronic submissions.
• Mentor, guide and train direct reports.
• May travel up to 15%.

Skills

Regulatory Affairs

Promotional material review

FDA OPDP requirements

Cross-functional collaboration

Education

Bachelor's degree

Chemistry/Biology/Pharmaceutical Science

Tools

eCTD submissions

Regulatory submissions management

Job description

Revance Therapeutics, Inc. is seeking a Regulatory Affairs Manager to oversee regulatory activities across non-clinical, clinical, CMC, and Ad Promo for investigational and marketed products.

You will collaborate cross-functionally to ensure compliance and strategic alignment throughout the product lifecycle in a fast-paced environment. The ideal candidate has deep experience with INDs, CTAs, BLAs, global submissions, and promotional material reviews, with strong communication skills and the