(REMOTE) Associate Director/Director Regulatory Affairs - Oncology

Company: Discover International
Location: Saint Louis
Posted on: June 24, 2022

Job Description:

This opportunity will give someone the chance to work with a company with over 110 years of expertise in the pharma industry. Work with one of the leading organizations in developing the regulatory strategy in the field of oncology, as well as rare diseases and immune disorders.The Role:

• Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communications via contact reports.
• Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.
• Participate in global product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activitiesExperience
  • Bachelor's Degree in chemistry, biology or other related scientific discipline required
  • 10 or More Years in the pharmaceutical industry preferred
  • Oncology experience is a must
  • 4 or More Years in global regulatory affairs, NDA, sNDA, BLA filing to FDA preferred
  • Eligible to work in the U.S.

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