Quality Assurance Regulatory Affairs

SONALBEN NAKRANI

* ********* ** ******* ****, NJ 08824 609-***-**** ad5c2q@r.postjobfree.com OBJECTIVE

Pursuing career in the field of Regulatory Affairs to foster my intellectual ability and professional growth that will utilize my regulatory, manufacturing, and quality assurance knowledge and experience to the best.

EDUCATION

Master’s of Science in Regulatory Affairs & Health Policy MCPHS University Boston, MA Dec 2017

GPA:3.91/4.00

Bachelor’s of Science in Pharmacy Veer Narmad South Gujarat University India May 2005 GPA: 3.25/4.00

EDUCATION DETAILS

• FDA regulations and requirements for Drug and Medical device approval process like IND, CTA, NDA, ANDA, OTC, BLA, 510(k), PMA, IDE, QSR and MDR.

• CAPA, ICH Guidelines, and Risk Management ISO 14971

• European, Japanese, Canadian, Russian, and Australian Regulatory Requirements.

• Laws and regulations governing Human Research

• Regulations for Orphan and Pediatric Drug Development COURSEWORK

CASE STUDIES

Regulatory Strategy for Orphan and Pediatric Drug Development for subset of Thalassemia Researched on Orphan Drug Development Pathway for Oral Iron Chelator for Beta Thalassemia, regulatory strategy with respect to other emerging markets like Brazil, EU, Russia, and Italy, and possible Pediatric development plan.

Regulatory Development Plan for Icatibant for the treatment of Hereditary Angioedema Principles of Quality Assurance and Control Health Epidemiology Statistics in Clinical Research Law and Health Policy of Drugs and Devices FDA and Regulatory Affairs Introduction to Health Policy and Management International Regulatory Affairs Data Analysis and Presentation Capabilities Researched on clinical and nonclinical development procedure and possible primary and secondary endpoints for Icatibant and fictional new drug.

Design/Technology transfer

Researched on contributions of Design control, Risk management and Production processes to create the Device Master Record or the Master Production and Control Record and recommendations on it. Regulatory challenges of Indian Pharmaceutical Industry Presented challenges such as drug quality and GMP compliance, internal controls, secured data and clinical trial quality systems, drug pricing and regulatory data protection. EXPERIENCE

Internship Neel-Nayan Pharma Pvt Ltd India (1st June to 14th June 2004, May 2005 - January 2006)

• Completed internship in Quality Control & Quality Assurance department

• Supported all API and non-API testing

• Observed microbiological lab testing

• Provided analytical support for laboratory compliance following SOPs and training procedure and basic wet lab testing

Pharmacist Metas Adventist Hospital India February 2006 – October 2007

• Reviewed prescription orders to determine accuracy and suitability

• Work closely with doctors and nurses in the evaluation of patients’ needs

• Completed prescription orders and labelled with patient information dosage recommendations and safety precautions that should be taken

• Researched the positive and negative effects of different medications on hospital patients

• Accepted and recorded shipments of pharmacy supplies then organize and stock them Pharmacist Jivan Jyot General Hospital India November 2007 – March 2015

• Dispensed medications according to the inpatient physicians' orders and outpatient physician's prescriptions

• Monitored pre-packaging and labeling of medications in unit dose quantities for the patients

• Responded to queries regarding drug availability, dosages, indications, and compatibility

• Contact the physicians to confirm the details of prescriptions

• Recorded medications and filled nursing and staff requisitions SOFTWARE SKILLS

• MS Word, MS Excel, Outlook and MS PowerPoint

OTHER ACTIVITIES AND SKILLS

• Participation in 56th conference of Indian Pharmaceutical Congress (IPC) 2005, India

• Excellent verbal and written communication skills

Contact this candidate