Sophy Abraham, Ph.D, RAC
Head of Regulatory Affairs at Elite Laboratories Inc
Greater New York City AreaPharmaceuticals
Previous
DAVA Pharmaceuticals, Inc., Teva Pharmaceuticals, Ivax
Education
Maharaja Sayajirao University, Baroda
297
connectionsConnectSend Sophy InMailMore options
www.linkedin.com/pub/sophy-abraham-ph-d-rac/9/664/414
Background
Summary
Preparation, review, and submission of high quality regulatory submissions, ANDAs, amendments and post-approval supplements in accord with regulatory guidelines with minimal guidance.
Change control review and assessment of control documents to determine the appropriate regulatory mechanism and documentation for submission to regulatory agencies.
Review of DMF and Technical Packages received from vendors and manufacturing sites.
Interact effectively with cross-functional business units as required to prepare documentation for pre-approval and marketed products.
Train and mentor new associates on change control assessments, review of technical documents, and regulatory submission requirements.
Assign change control approvals routed through electronic document management systems to associates.
Assist management in the review of SOPs, technical documents and regulatory submissions.
Experience
Head of Regulatory Affairs
Elite Laboratories Inc
October 2014 – Present (4 months)Northvale, NJ
Regulatory Affairs Consultant
DAVA Pharmaceuticals, Inc.
June 2014 – October 2014 (5 months)DAVA Pharmaceuticals
Teva PharmaceuticalsSr. Regulatory Associate
Teva Pharmaceuticals
2006 – April 2014 (8 years)
(Open)1 recommendation
Diane Harper, PhD, JD, RAC
Diane Harper, PhD, JD, RAC
Associate Director - CMC Regulatory Affairs at Acorda Therapeutics, Inc.
Endorsement of Sophy's regulatory skills and expertise.View
Sr Research Associate
Ivax
1994 – 2006 (12 years)
(Open)1 recommendation
Sohagi Parmar
Sohagi Parmar
Method Validation Reviewer at Tris PHARMA
Sophy is very detailed oriented scientific professional and excellent working abilities in ARD and Regulatory areas.View
Post Doctoral Associate
Rockefeller University
1988 – 1991 (3 years)
