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RssRegulatory 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

Plainsboro, NJ

About Me

Industry:

Science & Biotech

Occupation:

Clinical Regulatory Affairs
 

Education level:

Master

Will Relocate:

Yes

Location:

Plainsboro, NJ