[Hiring] Manager, Regulatory Affairs @Revance

Role Description

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%.

Qualifications

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

Requirements

• 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.

Benefits

• 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!

Company Description

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 .