Senior Director/Head of Regulatory Affairs

This biotech startup uses a proprietary platform that enables the discovery and development of potential therapies for a broad spectrum of diseases.  They are seeking a Senior Director/Head of Regulatory Affairs who can develop and lead regulatory strategies for all aspects of their early-stage rare diease programs (pre-clinical, clinical, and CMC).   Reporting to the CMO, you will establish the Regulatory function for the organization while advancing the company’s programs.  This company offers great science, a transparent and fun company culture, and unlimited paid time off!  Now is an ideal time to join this growing organization and make an impact on patients in need. 

Responsibilities:

  • Develop and lead regulatory strategies for a portfolio of early-stage programs.
  • Manage the planning, preparation, submission, and maintenance of INDs, IMPDs, NDAs, BLAs, MAAs, Orphan Drug Applications, Pediatric Investigational Plans, and other regulatory submissions as appropriate.
  • Lead Regulatory sub-teams by providing strategic guidance across the different clinical programs to write, critically review, and ultimately obtain Health Authority approvals.
  • Function as the primary liaison with FDA and other regulatory agencies.
  • Continually monitor newly published FDA guidelines and international guidance documents with respect to our multiple current and future development programs.
  • Provide training on applicable requirements for scientific & clinical staff as required
  • Manage external Regulatory services vendors (publishing, CMC, etc.)
  • Serve as a subject matter expert on Regulatory Affairs processes.
  • Advise program leaders with relevant expertise where needed.
  • Review and edit technical documents provided by the clinical, clinical pharmacology and nonclinical functions and extract information necessary for regulatory submissions.
  • Establish regulatory SOPs and develop regulatory budgets.
  • Ensure adherence to relevant regulatory guidance and regulations.

 Qualifications:

  • Bachelor degree required. Advanced degree, such as PharmD, PhD, MS preferred.
  • Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
  • Regulatory experience with rare disease programs is required.
  • Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, and/or MAAs.
  • Direct experience in initiating and conducting successful interactions within FDA or other Health Authorities.
  • Experience with Orphan Drug Applications, Fast Track Designations, and/or Breakthrough Designations desired.
  • Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, and regulatory responses.
  • Strong global experience and knowledge of US and global regulatory requirements and guidelines for US FDA, EU EMA, and other global health authorities.
  • Must be collegial, collaborative and open to feedback from others across the organization.
  • Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner.
  • Must be flexible and comfortable with ambiguity in a small company environment.
  • A self-starter who thrives in a dynamic & fast-paced organization and who is ready to embrace the challenge of establishing a Regulatory department from the ground up.

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