Manager, Regulatory Affairs

Revance

. Manage advertising and promotional submissions (2253s) related to the BLA and serve as the Regulatory Affairs representative on the Promotional Review Committee.

Posted 10/27/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong focus on managing submissions for drugs and biologics, ensuring compliance with US, EU, and international regulatory requirements. Proven ability to mentor teams and collaborate cross-functionally to deliver organized and scientifically valid applications.

Highest-signal resume keywords

Regulatory Affairs CertificationPromotional Material ReviewECTD Submission PreparationRegulatory Documentation ManagementInterfacing With Regulatory Authorities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIND/CTA PreparationBLA/MAA SubmissionRegulatory Documentation InfrastructureLifecycle ManagementFDA OPDP RequirementsNon-Clinical Module ReviewClinical Module ReviewCMC Module ReviewCross-Functional Collaboration

Soft Skills

MentoringTrainingCollaborationCommunicationLeadership

Tools & Technologies

E-Submission VendorsRegulatory Documentation Systems

Certifications & Qualifications

Regulatory Affairs Certification

Industry Keywords

Pharmaceutical Regulatory AffairsDrugsBiologicsUS Regulatory RequirementsEU Regulatory RequirementsHealth Canada RegulationsAustralia Regulatory RequirementsICH GuidelinesInvestigational ApplicationsMarketing Applications

About the role

Key responsibilities & impact

Manage advertising and promotional submissions (2253s) related to the BLA and serve as the Regulatory Affairs representative on the Promotional Review Committee.
Translate local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Manage preparation, review, and submission of regulatory documents across non-clinical, clinical, and CMC modules for IND/CTA, BLA/MAA, and other global submissions.
Manage e-submission vendors as needed.
Collaborate with contributing authors across functional areas on submission content.
Ensure timely preparation of organized and 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.
Travel up to 15% as required.

Requirements

What you’ll need

Bachelor’s degree & 5+ years’ directly related experience.
Direct experience in promotional material review and knowledge of FDA OPDP requirements.
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.
Bachelor’s degree in Chemistry, Biology, Pharmaceutical Science or a related field is preferred.

Benefits

Comp & perks

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!