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Revance Therapeutics Verified
Biotechnology, Pharmaceuticals, Aesthetics, Medical Devices

Manager, Regulatory Affairs

RemoteRemoteFull TimeManager / HeadPosted 11 days ago

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Required skills

  • Regulatory Affairs
  • promotional material review
  • FDA OPDP
  • INDs
  • CTAs
  • BLAs
  • global authority interactions
  • e-submission vendors
  • eCTD
  • US

Nice to have

  • Chemistry
  • Biology
  • Pharmaceutical Science
  • drugs/biologics
  • lifecycle management
  • regulatory authorities

Role summary

The Regulatory Affairs Manager will oversee all regulatory activities for investigational and marketed products, covering non-clinical, clinical, CMC, and advertising/promotional areas. This cross-functional role ensures strategic alignment and compliance throughout the product lifecycle by partnering with internal and external stakeholders. The ideal candidate possesses a strong understanding of regulatory requirements for development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands-on, fast-paced position requiring flexibility, attention to detail, and excellent communication skills. The role includes managing advertising and promotional submissions (2253s), providing regulatory expertise, preparing and submitting regulatory documents, collaborating on submission content, interacting with regulatory agencies, and executing regulatory documentation infrastructure. The position also involves mentoring direct reports and may require up to 15% travel.

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 at www.revance.com.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.

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