Search Jobs

Associate Director Regulatory Affairs

Camden Metro Area, NJ

Posted: 07/09/2019 Job Type: Scientific Job Number: JN -072019-25193
  • PhD preferred - Scientific Discipline
  • At least 5 years of regulatory experience including advanced hands on training in NDA submissions for FDA Approval
  • Expertise in ICH , FDA and EU and other major regulatory systems
  • Experience with various types of US submissions - solid dosage forms preferred.
  • Experience working and communicating with the FDA, including coordinating and managing meetings for
    scientific advice
  • Familiarity with clinical trials
  • Module 1 documents for US NDA, sNDA labeling supplements, etc.
  • Remain current on Regulatory Intelligence, new guidance documents
  • Contribute the US regulatory perspective as required
  • Collaborate closely with external partners for regulatory considerations, strategy and key regulatory documents
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.