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Director/Senior Director, Regulatory Operations and Submissions Management

Reference Number: 3773
Location: MA

Our client is a biopharmaceutical company.  They have asked us to assist them in their search for a Director/Senior Director, Regulatory Operations and Submissions Management. 

Major tasks and responsibilities will include:

  • Provides leadership to the Regulatory Operations group and cross-functional teams.
  • Manages and develops a competent and technically skilled submission operations organization.
  • Works closely with Regulatory Affairs to effectively identify, plan for and manage timely completion of development programs regulatory milestones.
  • Manages the successful delivery of Regulatory submissions for all development programs and projects.
  • Manages regulatory budgets to support all phases of drug development projects.
  • Ensures health authority submissions are compiled accurately, in their entirety, and within specified timelines while maintaining quality.
  • Prepares and manages the Health Authority Application Tracker as appropriate.
  • Manages and tracks the internal review of larger Health Authority applications
  • Maintains constant communication with internal team and eCTD vendor to ensure timely issue identification, resolution, and implementation.
  • Supports Development Teams in understanding the document requirements for Health Authority submissions.
  • Ensures workload is adequately delegated amongst Regulatory Operations staff so timelines are met.
  • Sets and manages expectations, and highlights / resolves issues.
  • Acts as primary liaison with publishing vendor(s) for all eCTD submissions. 
  • Oversees the compilation and collaboration with the eCTD vendors for all major and routine submissions.
  • Prepares and maintains SOPs.
  • Manages the Regulatory Information and Document Management System for all regulated documents to ensure proper lifecycle management, track / monitor development programs regulatory objectives / goals, and to ensure the archival / storage of regulatory submissions.

We seek candidates with the following qualifications:

  • Bachelor’s degree required.
  • Master’s degree highly preferred.
  • Must have 10+ years of directly related pharmaceutical industry experience.
  • Requires prior interaction with eCTD vendors and experience with outsourcing.
  • Experience and knowledge in the preparation of global regulatory submissions required.
  • Must have experience with an electronic document management system and/or workflows.
  • Requires knowledge of eCTD publishing tools and content/format requirements
  • Must have working knowledge of ICH and FDA guidance relevant to electronic regulatory submissions.
  • Requires experience managing people and projects.
  • Requires the ability and willingness to frequently travel.

If interested, please email your resume as a Word attachment to us, reference 3773.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.