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Position: Part Time

Location: Newtown, PA (in-house)

Under minimal guidance, prepares regulatory applications and submissions such as amendments, supplements, Investigational New Drugs (INDs), New Drug Applications (NDAs), Annual Reports, Periodic Safety Reports, and FDA control documents in accordance to FDA guidelines. Represents Regulatory Affairs on project teams. Provides assistance to Sr. Management, as necessary.

 

Duties and Responsibilities

  • Helps coordinate and prepare regulatory submissions in eCTD format
  • Responsible to ensure compliance with all current requirements and guidances for IND & NDA
  • Liaises with internal departments to ensure adequate resources are available
  • Responsible for all controlled correspondence with US FDA
  • Review documents for eventual IND/NDA inclusion
  • Responsible for dossier compilation and managing the publishing
  • Responsible for formulating and responding to Regulatory body deficiencies or queries
  • Meets face-to-face with clients, including attendance at bid defenses as needed
  • Participates in regulatory agency meetings and audits as may be required

 

Minimum Requirements

  • Must have 5+ years of actual regulatory affairs experience in IND & NDA process
  • Completed Bachelor’s degree in a STEM discipline
  • Knowledgeable of current pharmaceutical industry and applicable regulations and guidances for submitting INDs, NDAs and Amendments
  • Willing to be a partner and team player in the various decision-making committees within the company
  • Strong ability to compile, manage, and interpret data
  • Comfortable with setting personal work load timelines and the ability to manage changing priorities
  • Excellent oral and written communication skills
  • Sufficient knowledge of using computer software such as Microsoft office, spreadsheets, graphs/charts, databases, etc.

 

Preferred Skills/Knowledge

  • Completed Master’s in a RA/QA, Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering concentration is preferred
  • 8+ years pharmaceutical industry experience in regulatory affairs in the IND/NDA space
  • Ability to read and interpret regulatory guidelines as they apply to submission documents
  • Experience with product development projects and developing strategies during early phase formulation development
  • Experience in eCTD Submissions