Regulatory Submissions Sr. Manager or Associate Director

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 (or Associate Director) of 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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