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Regulatory Affairs Director

Company: Dennis Partners
Location: San Francisco
Posted on: January 15, 2021

Job Description:

Regulatory Affairs Director or Associate Director Posted on: October 1, 2020 This small but growing Bay Area pharmaceutical company has one approved product and a very strong pipeline of novel therapeutics for the treatment of rare diseases. They are seeking a Regulatory Affairs Director or Associate Director that can contribute to and execute on regulatory strategies for multiple programs in development. This individual will be responsible for the preparation and submission of global applications while also interacting with regulatory authorities. Now is an exciting time to join this innovative organization and improve the lives of patients around the world!Responsibilities:

  • Develop and implement global regulatory strategies for multiple programs in development including rare disease indications.
  • Prepare, coordinate, and manage various regulatory submissions including INDs, CTAs, orphan drug applications, NDAs, and routine maintenance submissions.
  • Lead cross functional project teams while providing regulatory expertise, project management oversight, direction, planning, and execution.
  • Prepare for and participate in interactions with FDA and global regulatory agencies.
  • Identify, drive, track and deliver on key milestones/objectives.
  • Serve as primary liaison with outside contractors to obtain and complete regulatory documents/data.
  • Provide regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
  • Prepare regulatory operations Standard Operating Procedures (SOPs); provide regulatory review of SOPs from other departments as necessary.
  • Act as key liaison for ordering publications, guidelines, FOI requests, etc. for the department.
  • Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends.Knowledge and Skills:
    • BS. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
    • 8+ years of experience in Global Regulatory Affairs for pharmaceutical drugs and/or biologics.
    • Direct experience in preparing regulatory submissions (INDs, CTAs) required. Experience with Marketing Applications (NDA, BLA, and/or MAA) a plus.
    • Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule drug products.
    • Experience with rare disease indications a plus.
    • Strong project management and organizational skills with emphasis on attention to detail
    • Regulatory Affairs Professional Society or similar certificate a plus
    • Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization.
    • Ability to work independently on multiple projects with tight timelines and minimal supervision.
    • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
    • Must be a team player who is comfortable wearing many hats in a small biotech environment.Apply for this Position Your Name*
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      This entry was posted in . Bookmark the permalink . Minimum Education University - Bachelor Degree Dennis Partners has, and always will, stand for inclusivity, anti-racism, and the empowerment of our candidates, clients, team members, and community. Dismiss Learn More Here

Keywords: Dennis Partners, San Francisco , Regulatory Affairs Director, Executive , San Francisco, California

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