14 days old

Sr. Manager, Regulatory Affairs

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    134924201
Category: Clinical & Regulatory Affairs
Location: Newark, California

Description

Job Summary
The position is responsible for managing Regulatory Affairs activities for assigned investigational development products from early development through product approval, including regulatory submissions. This individual is responsible for maintaining an awareness of relevant federal and international regulations and policies to optimize Revance's regulatory input to assigned projects and teams.

Essential Duties/Responsibilities
Executes regulatory strategies for earliest possible approvals for Revance development programs
Assists RA team in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams
Coordinates the drafting/review/compiling of IND/CTA, BLA/MAA and other global submissions documents; may manage e-submission vendors
Collaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, annuals)
Ensures timely preparation of organized and scientifically valid applications
Interacts with regulatory agencies on defined matters
Electronically format and prepares submissions for publishing. Plan regulatory submission deliverables, and ensure quality, accuracy, and submission-readiness per regulatory agency guidance and specifications, and internal procedures.
Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions
Assists in the development and implementation of documentation standards, templates, and procedures related to the formatting, publishing, and archiving of electronic (eCTD) submissions.
Provides Veeva Vault RIM Platform System Support for initial implementation and system upgrades.
Provides Business subject matter expert support for the Veeva Vault RIM platform including training, customer education and troubleshooting issues.

Education
  • Minimum of a Bachelor degree in Chemistry, Biology, Pharmaceutical Science or a related field


Preferred:
  • Regulatory Affairs Certification or equivalent training and familiarity with biologics and biosimilars, preferred.


Experience

Minimum Required:
Minimum of 5-7 years in pharmaceutical Regulatory Affairs or Regulatory Operations with a focus in drugs/biologics
Experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format
Electronic submission experience
Knowledge of US, EU, Health Canada, and ICH regulatory requirements
Preferred:
Experience directly interfacing with regulatory authorities preferred
Knowledge, Skills and Abilities
Minimum Required:
Must be Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook)
Strong written and verbal communication

Preferred:
Ability to multi-task, pay close attention to detail, and follow projects through to completion. Excellent organizational, prioritization, and planning skills.





PI134924201

Posted: 2021-04-24 Expires: 2021-05-26

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Sr. Manager, Regulatory Affairs

Revance Therapeutics Inc.
Newark, CA 94560

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