Regulatory Affairs Associate/Quality Assurance

Available August ****

EDUCATION

Northeastern University, Boston, MA, USA JUNE 2012

Master of Science (M.S) in Regulatory Affairs for Drugs, Biologics and Medical Devices

Relevant coursework:

New Drug Development, Medical Device Development, Biologics Development, Food Drug and Medical Device Law, Managing International Clinical Trials, Human Experimentation: Methodological Issues Fundamental to Clinical Trials, European Union Compliance Process and Regulatory Affairs, Practical Aspects of Regulatory Compliance, Canadian Latin American and Asian Regulatory Affairs

World Intellectual Property Organization JULY 2011

Certificate course on Intellectual Property

University of Mumbai – Saraswathi Vidya Bhawans College of Pharmacy, Mumbai, India MAY 2010

Bachelor of Pharmaceutical Sciences

Relevant coursework: Forensic Pharmacy and Drug Regulations, Hospital Pharmacy, Pharmaceutical Management, Pharmaceutics and Drug Delivery, Bio-pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Analysis, Biochemistry, Biotechnology, Anatomy and Physiology, Pharmacology

WORK EXPERIENCE

Regulatory Affairs Co-op: Genzyme Corporation, Cambridge, MA Jan 2012- June 2012

• Prepared Investigational and Post Marketing Annual Reports for monoclonal antibody with multiple indications

• Prepared IND safety reports for an Investigational Agent in Multiple Sclerosis

• Prepared general clinical amendments to the IND

• Supported the Regulatory team for BLA submission development including participation in cross functional strategic team meetings

• Developed an orphan drug application for potential pediatric initiative

• Participated in preparation for clinical inspection readiness

• Research into Regulatory statutes and changing regulations

Production and Quality Assurance Intern: Pfizer India LTD, Navi Mumbai, India June 2009- July 2009

• Prepared batch manufacturing records and assisted in reviewing Standard Operating Procedures

• Assisted in preparation of deviation reports and OOS reports for Quality department

• Assisted in the manufacture of liquid orals, tablets, capsules and surgical powders

• Performed quality control analysis such as hardness, drug content analysis, disintegration and dissolution on tablets, capsules and Active Pharmaceutical Ingredients

• Analyzed drug content in tablets, capsules and liquid oral preparations using HPLC and UV spectrophotometer

• Assisted with sampling, warehousing, dispensing of raw materials used in formulation

SKILLS

Regulatory Affairs Proficiency:

• Knowledge of FDA and IRB regulations, ICH guidelines, ISO 9001 and ISO 13485 quality standards; Knowledge of FDA regulations for IND, BLA, NDA, ANDA, 510(k), IDE, PMA process, HDE, PMA and 510(k) supplements; Quality Management System and Compliance, Design Controls, GCP, GLP, GMP standards, Advertisement and Labeling Regulations (SPL, PLR Format), Regulatory Compliance, Post Licensure Requirements

• EU healthcare product regulatory environment and EU directives, the organizations involved; Regulatory Strategy for Development, Approval and Compliance for Medicinal Products and Medical Devices(CE marking) in the EU, Good understanding of Canadian, Latin American and Asian Regulatory Affairs

• Sound knowledge of clinical protocol development, Informed consent process, Regulations governing clinical trials and documentation of results, Adverse event reporting, Ethical issues involved in clinical trials, Preparing for and managing clinical studies on a global scale, Approval timelines and procedures for conducting clinical trials in Asia, Latin America, Europe

• Post marketing surveillance, CAPA, OOS, Auditing, REMS

Computer skills:

• Comprehensive knowledge of MS Word processing, MS Excel spreadsheet, MS PowerPoint, MS Access Adobe Acrobat, Microsoft Outlook and windows operating system

ACADEMIC PROJECTS

• Regulatory Development Plan: Worked on a project to develop a regulatory plan for a combination product comprising of a special IV device filled with an anti-inflammatory drug and Monoclonal antibody for treatment of advanced stage lung cancer June2011

• Manufacturing Exercise: Participated in a GMP compliant manufacturing exercise under simulated conditions in a classroom and also drafted a Batch Manufacturing Record for the exercise May 2011

• Phase III Clinical Trials: Presented a project which describes the general plan, project goals, site feasibility studies for Phase III clinical trials on a global scale March 2011

• Fictional IND: Drafted a Regulatory Development Plan for a fictional drug, Request for Special Protocol Assessment for Carcinogenicity Study and A Pre-IND Meeting Request March 2011

• Drafted a response to FDA warning letter October 2010

• Size Exclusion Chromatography: Presented a paper on chromatographic separation techniques concentrating on Size Exclusion Chromatography February 2009

ACHIEVEMENTS

• Recipient of International Students Scholarship at Northeastern University for Regulatory Affairs Program

• Served as the Sports Secretary in the Academic Year 2008-2009, and the sports representative in Academic Year 2009-2010

PROFESSIONAL MEMBERSHIP

• Regulatory Affairs Professional Society (RAPS) student member

References available on request

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