Anand Parikh

617-***-**** aca72h@r.postjobfree.com

EDUCATION

Goldey Beacom College, Wilmington, DE May 2012 - Present

Master of Business Administration in Healthcare

Northeastern University, Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices April 2012

Activities and Achievements:

• Certificate in Patent Drafting as per Intellectual Property (IP) Rights

• Member of Regulatory Affairs Professional Society (RAPS)

• Member of Drug Information Association (DIA)

• Student Coordinator of 'Sanskriti', a Graduate Indian Student Association of Northeastern University (2011-2012)

University of Mumbai, MET College of Pharmacy, Mumbai, India

Bachelor of Pharmacy May 2009

WORK EXPERIENCE

Axar Pharma Irvine, CA

Regulatory Affairs Associate Intern Aug 2012 - Present

• Assisted in gathering, reviewing and compiling data for IND and NDA dossier submission including QC, tracking and archiving

• Evaluating and modifying pharmacokinetic and pharmacodynamics document such as TK reports, ETS reports and protein binding reports

• Authoring these regulatory documents in an electronic submission ready format for IND submission

• Conducted literature search for robust and rational regulatory strategies for new drug products

• Conducting meetings with Contract Research Organization and communicating project deliverables

• Maintaining, reviewing and utilizing tools and document systems used in electronic regulatory submissions

• Prepared and updated regulatory database of the product in Microsoft Access

• Coordinated with the manager to create and maintain database for SOPs

• Proofread product labels, inserts, SOPs and containers

• Supported and reviewed documents for change control, annual reports, PSUR safety reports, SPL and labeling changes

• Reviewed and assessed regulatory documents like CBE 30, CBE 0, SOPs, BMRs and DMFs

Manja Pharmaceuticals Pvt. Ltd. Mumbai, India Jan - Jun 2010

QC/QA Intern

• Abetted basic principles and functions of production, quality control and quality assurance

• Designed protocols for in-process quality control tests of oral dosage forms

• Performed quality control tests on raw material and finished products

• Conducted line clearance tasks in packaging and labeling department

• Executed statistical sampling for product acceptance and defects

• Assisted Manager in reviewing and ensuring the manufacturing process in compliance with GMP

• Drafted and updated SOP and batch manufacturing records (BMR)

Cognizant Technical Solutions May - Dec 2009

Junior Data Analyst for Drug Safety and Pharmacovigilance

• Documented and processed cases along with reporting of adverse events

• Performed triage and evaluation of adverse events from clinical trials and post marketing as per the protocol

• Prepared follow up reports and responsible for accurate and systemic documentation in the database

• Uploaded accurate and consistent data into Argus database

• Working with Argus application for follow up cases

• Coding adverse events using MedDRA for all cases

• Drafted precise narratives of adverse events cases from the source documents

• Performed quality review on cases as per the SOPs to ensure information reported is complete

• Primarily responsible for triage and case processing of ICSR

• Voice and accent training to take calls from patients and health care professionals

• Reviewed and assessed all source documents

• Accurately identified and captured adverse events related to marketed and clinical trial drugs

• Maintained accuracy, uniformity and regularly updating of safety databases

• Captured and reported the adverse events accurately into the adverse event reporting forms

ACADEMIC PROJECTS:

• Drafted a fictional IND, NDA, BLA and Annual report submissions for a drug and a biologic

• Developed a regulatory strategy for marketing a hypothetical combination product containing drugs, biologics and medical devices

• Drafted an informed consent for enrollment of subjects in Phase 1 clinical trial of life threatening disease

• Designed a fictional Phase III trial for a drug for Myelofibrosis

• Participated in a manufacturing exercise of drug product in compliance with cGMP simulated environment

• Submitted a paper on conducting multicenter clinical trials in US, EU, China and Latin American Countries

• Presented a paper on Reprocessing of Single Use Medical Devices

SKILLS

Regulatory Skills:

• Premarket approval (PMA), PMA supplements, 510K, Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE)

• IND, NDA, ANDA, BLA, CTD, eCTD’s, PSUR, DSUR, SUSAR, CTAs, MAAs, NDC number, Establishment registration

• cGMP, GLP, GCP, Regulations governing Clinical Trials

• Labeling Requirements, Annual reports, Case Report Forms (CRFs), Serious Adverse Event reports, Change controls, Eudravigilance

• FDA and IRB regulations, ICH and GHTF Guidelines, TMF, Corrective Actions and Preventive Actions (CAPA) and Medical device reporting

• Quality System Regulations: 21 CFR 820, ISO 13485, ISO 9001:2000

• Informed consent process, ethical issues involved in clinical trials, managing international clinical trials and multicenter clinical trials

Computer Skills: Windows, MAC, ISI toolbox, Microsoft Office (Word, Excel, PowerPoint, Outlook), Adobe/Acrobat Proviso

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