Regulatory Specialist
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