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Regulatory Affairs Associate, New Jersey
Regulatory Affairs professional with a strong regulatory and compliance foundation, well-versed in the laws, regulations and requirements of the FDA; over six years of experience as an International Coordinator for a pharmaceutical organization, currently completing a graduate degree in Regulatory Affairs in Drug Development, Biologics and Medical Devices, studying all facets of regulatory requirements including processes and procedures in clinical research , (GLP / GCP), regulatory submissions (IND, NDA, ANDA, PMA and BLA), safety guidelines, risk assessment and evaluations (REMS), quality system regulations, strategic planning scenarios, data management, record keeping and reporting with emphasis on clinical trial operations.
Clinical Regulatory Affairs
About Me
Industry: |
Science & Biotech |
|---|---|
Occupation: |
Clinical Regulatory Affairs |
Education level: |
Master |
Will Relocate: |
Yes |
Location: |
Plainsboro, NJ |
