Why would I want this job?

Senior Manager, Regulatory Affairs for a provider of affordable, high-quality pharmaceuticals which deliver enhanced value to patients, customers and the healthcare system.

What would I be doing?


  • Responsible for preparing and submitting NDA annual reports, post-approval supplements, and other submission activities in eCTD format.
  • Provide regulatory assessments of CMC change controls.
  • Define, prepare, and submit relevant documents required to support approvals of supplemental NDAs.
  • Knowledgeable of relevant CMC regulations and FDA guidance documents.
  • Maintain and update establishment registrations and drug listings.
  • Maintain and update regulatory SOPs and support the review and implementation of policies and procedures.
  • Provide regulatory support of state and FDA inspections.
  • Act as the designated representative for company’s manufacturer and wholesale distributor licenses.

What would make me qualified?


  • Bachelor’s degree in chemistry or equivalent


  • Proficiency in Spanish is desirable


  • 5+ years in regulatory affairs


  • Strong written and oral communication skills

Specific Knowledge:

  • Experience with Trackwise and SAP