Regulatory Affairs Specialist
Resume:
Rushin Jhala
Cranbury, NJ 08512
******.*****@*****.***
Dear Sir/Madam,
While researching your company website, I learned your need for a Regulatory Affairs Specialist I/II. I would like to express my interest in this position.
I have completed my Masters in Drug Regulatory Affairs at Massachusetts College of Pharmacy and Health Sciences. Evidence of my regulatory and analytical skills can be seen in my responsibilities as Regulatory Affairs Database Coordinator at ConvaTec Inc and Regulatory Affairs Associate at DRA Solutions, DRA Consultants Inc. My educational background in regulatory affairs, combined with my practical experiences, has been excellent preparation for a career with your esteemed company. My working experience has made me a good team player as well as an efficient leader.
Please review the enclosed resume, which summarizes my qualifications and experience and consider my application for your Regulatory Affairs Associate position. I look forward to meet you to discuss the positive contributions I would offer as a member of your organization.
Thank you for your consideration.
Sincerely,
Rushin Jhala
Rushin P. Jhala
253 Princeton Arms N II, Tel: 617-***-****
Cranbury, NJ 08512 E-mail: ******.*****@*****.***
Educational Qualifications:
• Massachusetts College of Pharmacy and Health Sciences, Boston, MA
Master of Science in Drug Regulatory Affairs (December 2010)
• Institute of Pharmacy, Nirma University, India
Bachelors in Pharmacy (May 2008)
Professional Experience:
• Regulatory Affairs Database Coordinator, Convatec Inc. (May 2011 - Present)
o Working on the 510(k) clearance of Class II Urinary Catheters for adult and pediatric population.
o Working with the FURLS database to comply with the company’s Establishment Registration and Device Listing information.
o Interacting with project team members from Regulatory Affairs, Supply Chain, Marketing and Quality departments to verify and compile medical device regulatory data in preparation of entry into a data tracking system.
o Facilitating regulatory requests received from company’s business units present worldwide.
• Regulatory Affairs Associate, DRA Consultants Inc. (August 2009 - Sep 2010)
o As a team member facilitated 510(k) clearance of infusion pump in United States for one of the client
o As a key team member facilitated compliance of infusion pump with the guidance document
o Demonstrated key understandings of the 510(k) process to the client
o Led registration of Dietary supplement products in US for one of the client
o Prepared country specific reports on drugs and medical device regulations for Australia, Saudi Arabia, China and Turkey
o Prepared course material on drugs and device regulation for company’s Regulatory Certificate Program
o Led a team of six members for developing Newsletter for the company to track regulatory changes around the world
• Intern, Lincoln Pharmaceuticals Ltd. (April 2008 - July 2008)
o Underwent training in the Quality Assurance department; enhanced my analytical and interpersonal skills
o Performed experiments using disintegration and dissolution apparatus
• Intern, Lincoln Pharmaceuticals Ltd. (April 2007 – July 2007)
o Worked in the manufacturing department; handled Rotary press tablet manufacturing machine
o Training in various unit processes for the manufacture of tablets, i.e. blending, granulation, drying and compaction including in-process and release testing
Thesis:
• Performed extensive research on “Challenges faced by the Pediatric Medical Devices in United States and their possible solutions”
Skills:
• Regulatory
o Regulatory research of existing and emerging drugs and medical device laws and regulations and their application
o Knowledge of IND, NDA, ANDA, 510(k) and PMA submissions; dietary supplement registration
o Quality system regulation like cGMP
o Knowledge of international regulations in the fields of drugs and dietary supplements for countries like Australia, China and Saudi Arabia
o Understanding of United States health care system and reimbursement policies
• IRB
o Protocol revision and designing informed consent for IRB review
• Software skills
o Worked with SPSS, FURLS database.
o Proficient with MS Office (Word, Excel, Power Point, Access); Internet, E-mail
Projects:
• Seminars at Massachusetts College of Pharmacy and Health Sciences:
o Approaches to payment of research subjects
o Phases of clinical research and differences in Drug and Device world
o Innovation Endangered
o How to use SPSS software
• Decided Cost effectiveness of a new drug compared to standard drug using decision modeling
Relevant Coursework:
• Law and Health Policies of Drugs and Devices, FDA Regulations and Policy I, Product Development and Regulatory Policy II, Health Policy Development and Analysis, Statistics in clinical research, Protecting human research subjects, Advanced topics in regulatory affairs.
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