Regulatory Submissions Manager or Sr. Manager

My client is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases.  They are seeking a Senior Manager, Regulatory Submissions to lead the eCTD publishing for an upcoming BLA and an MAA.  You will build and manage timelines for regulatory publishing activities while managing and mentoring a junior staff member.  Now is an exciting time to join the gene therapy revolution!

Responsibilities:

  • Develop and implement regulatory eCTD submission project and resourcing plans for major marketing applications in the US and EU
  • Establish goals, and measure progress toward critical milestones for major regulatory submissions
  • Manage vendors to support regulatory submissions goals
  • Partner with regulatory team members as well as well as members of the Project Management, Commercial, Clinical, Medical Affairs, Clinical Operations, Nonclinical, CMC and Quality functions to ensure successful submissions
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
  • Effectively communicate on the status, objectives, risks, and mitigation plans associated with the various regulatory projects
  • Hire, train, and mentor a new Regulatory Submissions Associate

Knowledge & Skills:

  • A Bachelor’s degree or Master’s degree ideally in the life sciences
  • 5+ years of regulatory operations, submissions, and publishing experience
  • eCTD submission experience with a major marketing application (NDA, BLA, or MAA)
  • Experience using a document management platform and eCTD publishing software (like ARIM, eCTDXpress, FirstDocs, Documentum, Veeva, ISI Toolbox, etc.)
  • Proven ability to successfully plan for and manage simultaneous major marketing applications while overseeing the routine daily maintenance of existing regulatory applications
  • Experience working in a fast-paced, innovative drug development environment
  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
  • Outstanding communication, analytical, and organizational skills

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