Manager, Regulatory Affairs

Job Summary:

The Manager, Regulatory Affairs 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: Executive Director, Regulatory Affairs
Location: Remote

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 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.

What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus.
• Flexible unlimited PTO, holidays, and 12 weeks' parental leave.
• Generous healthcare benefits, employer HSA contribution, 401k match, tuition reimbursement, 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."

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.