Sr. Manager, Regulatory Affairs

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.

·         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.

Minimum Required:

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.

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

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.