Regulatory Affairs Associate/senior Associate

Azurity Pharmaceuticals

Raleigh, NC, United States
On-site
Prepare and submit regulatory filings
Manage lifecycle of ind, nda, anda
Support interaction with fda
Azurity Pharmaceuticals is seeking a Regulatory Affairs Associate/Senior Associate in Raleigh, NC, to assist with regulatory filings and manage product lifecycles. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry and a commitment to patient-centric solutions

Job Summary

  • The Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.
  • The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc.
  • Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients.

Matching Summary

Match Score: 85

Azurity Pharmaceuticals is seeking a Regulatory Affairs Associate/Senior Associate in Raleigh, NC, to assist with regulatory filings and manage product lifecycles. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry and a commitment to patient-centric solutions.

Skills & Requirements

Must-have

  • prepare and submit regulatory filings
  • manage lifecycle of IND, NDA, ANDA
  • support interaction with FDA
  • provide regulatory guidance
  • assess impact of current regulations

Nice-to-have

  • patient-centric products
  • creative spirit
  • highly motivated individuals

Key Requirements

  • Bachelor of Science degree or advanced degree
  • Minimum of 3 years in pharmaceutical industry
  • At least 1 year in regulatory affairs
  • Excellent organizational and communication skills
  • Ability to work independently

Work Rights

Not specified

Tailored Resume

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