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PHARMACEUTICAL REGULATORY AFFAIRS

Results focused and detail oriented professional, knowledgeable in all areas of research including budgeting, GCP, IRB protocol and consent submissions, on-going regulatory and IRB phases and safety reporting. Analytical with strong background in technical writing and understanding of FDA and ICH regulations in drug and device development. Proficient in clinical trial methodology and in writing trial protocols and consents. A proven leader and an excellent communicator recognized for ability to establish and maintain effective working relationships across cross-functional teams and diverse individuals at any levels.

Core Competencies

Project Management & Coordination · Pharmaceutical Regulation · Process Evaluation · Quality Control

· Clinical Trial Data Management · Source Data Development · FDA and ICH Regulations Compliance

PROFESSIONAL EXPERIENCE

Robert Wood Johnson Medical School · New Brunswick, NJ 2012 – Present

Division of Cardiothoracic Surgery & Anesthesia – Regulatory Affairs

Perform activities supporting regulatory policy and compliance initiatives for the device studies. Assist in the planning, preparation and submission to FDA for 510(k) supplement. Communicate effectively with Investigational Sites and CRO’s.

Prepare 1572 for Therapeutic Studies Phase I through Phase IV.
Handle AE & SAE reporting to both FDA & IRB.
Participate in preparation and negotiation of research budgets.

Robert Wood Johnson University Hospital · New Brunswick, NJ 2011 – 2012

Clinical Research Center – Clinical Trials Intern

Prepared regulatory documents under supervision for a Phase 1 study. Organized the regulatory binder.

The Cancer Institute of New Jersey · New Brunswick, NJ 2003 – 2012

Division of Gynecologic Oncology – Research Teaching Specialist

Oversaw development, implementation and management of programs in oncology research. Managed budgetary affairs of the lab including decisions on equipment procurement and interaction with vendors.

University of Pennsylvania · Philadelphia, PA 2002 – 2003

Department of Animal Biology, School of Veterinary Medicine – Post Doctoral Research Fellow

Conducted research on the ubiqutination and the down regulation of interferon receptors. Performed invitro binding assays with synthetic peptides immobilized on beads.

University of Nebraska · Lincoln, NE 2001 – 2002

Department of Biochemistry – Post Doctoral Research Fellow

Performed experimental studies in selenoproteins and conducted various experiments related to thiol-based regulation and signaling. Handled purification and characterization of recombinant proteins using various chromatographic electrophoretic and mass spectrophotometric techniques.

EDUCATION AND CREDENTIALS

Masters of Science in Clinical and Translational Sciences, 2012

University of Medicine and Dentistry of New Jersey – New Brunswick, NJ

Ph.D. in Biochemistry, 2001

University of Kerala – Thiruvananthapuram, India

Masters of Science in Biochemistry, 1995

University of Kerala – Thiruvananthapuram, India

Member, Regulatory Affairs Professional Society · Member, American Association for Cancer Research

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