Manager, Regulatory Affairs

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

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 atWhat Revance invests in you:

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.