Regulatory Affairs Associate
Resume:
Nirav Desai
**B Smith Street, near Roxbury Crossing, Boston. MA- 02120
**************@*****.*** ● 617-***-****
EDUCATION
Northeastern University, Boston, Massachusetts April 2012
Masters in Regulatory Affairs Current GPA: 3.72 / 4.0
Relevant Courses: Introduction to Drug and Medical Device Regulation, New Drug Development Regulation,
Regulatory Overview of Biologics Development, Human Experimentation, Medical Device Regulation, Practical Aspects of Regulatory Compliance, Personal and Career development, Managing International Clinical trials and Global biotechnology product regulation in EU and US markets.
Mumbai University, India June 2010
Bachelors in Pharmacy First Class
Relevant Courses: Pharmaceutics, Biotechnology, Pharmaceutical Analysis and Biopharmaceutics.
Achievements: Selected as the Best Student to represent my college at the Rx-Inter College Competition held by the Indian Pharmaceutical Association (IPA).
EXPERIENCE
Nxstage Medical. Lawrence, MA- Regulatory Affairs Co-op January2012- Present
• Compiled different sections of the Technical File.
• Designed the Technical File Index.
• Trained on the SOP’s to perform all the roles of Regulatory Affairs Professional based on Quality Systems.
• Researched on various Articles and Journals for Hemodialysis and Hypotension.
• Retrieved a list of product complaints from MAUDE database of FDA.
• Assisted supervisor in creating risk assessment data for clinical safety evaluation.
Biogen Idec. Cambridge, MA- Fall C0-op- Regulatory affairs- CMC Sept. 2011- December 2011
• Introduce the concept of device master file (MAF) to the group.
• Developing filing strategies for the combination product consisting of an Auto-injector filled with a biologic.
• Conducting research and benchmarking industries to find a predicate device for the 510k submission.
• Review of a Clinical Trial Application.
• Organizing the sections and revising the different sections of the eCTD format of regulatory submissions.
• Presentation on Guidance for Industry for providing Regulatory Submissions in the Electronic format.
Biogen Idec. Cambridge, MA- Summer Co-op- Quality Assurance June 2011-September 2011
• Educated on SOP’s to perform review and approval of Validation plans.
• Audited the Manufacturing Facilities and trained on gowning.
• Performed carry-over calculation assessment and approval.
• Reviewed FMEA plans.
• Technology Transfer.
• Aided in Documentation and Archiving using Trackwise Database.
• Issued Protocol number.
• Conducted Change-over walk through to approve the change-in and change-out of the products in the manufacturing trains.
• P&ID walk through to approve the new equipment in the facilities.
• Evaluate and edit SOP’s.
• Generated and drafted Corrective and Preventive Action (CAPA) plans.
• Presented a poster on Carry-over calculation improvements.
Manufacturing Intern, Zydus Cadila Health Care, India May 2009-June 2009
• Assisted in R&D and Manufacturing of Tablets, capsules, Transdermal preparations and Parenterals.
• Aided in Quality Control test of the finished pharmaceuticals.
• Trained under the Pilot Plant and Lyophilization department.
Nirav Desai
15B Smith Street, near Roxbury Crossing, Boston. MA- 02120
**************@*****.*** ● 617-***-****
PROJECTS AT NORTHEASTERN UNIVERSITY
Managing International Clinical Trials October 2011
• Presentation on conducting clinical trials in different countries.
• Challenges to be faced and the country specific regulations.
• Approval time frames and Regulatory considerations for different countries.
Request for designation, application of combination product to FDA June 2011
• Prepared an application for a fictional combination product for obesity containing an implantable medical device and a drug Contrave
• Proposed the Request for Designation to the FDA and marketing approval following the ICH guidance for industry and 21 CFR part 312 and part 314.
GMP Manufacturing and Testing (Team Project) May 2011
• Prepared Batch Records, Test Records, Deviation Forms
• Manufactured a product under GMP simulated conditions.
• Tested products under GMP simulated conditions and investigated deviations and OOS incidents.
Conducted Audits as per 21 CFR parts 210 and 211 (Individual Project) May 2011
• Prepared the checklist for auditing parameters as per 21 CFR parts 210 and 211
• Conducted audits in order to check whether a restaurant can be used as a possible manufacturing site as per GMP.
Preparing Standard Operating Procedures document April 2011
• Prepared a Standard Operating Procedure for Calibration of Thermometers according to regulations.
Position Paper on Vaccine Controversy (Individual Project) February 2011
• Prepared a position paper on Vaccine Controversy issue, the most debated issue in the world of Biologics.
Informed Consent for Anti-Cancer Drug (Individual Project) January 2011
• Developed an Informed Consent for patient participation into Phase I clinical trials according to 21C.F.R. § 50.
IND and NDA application of Lapatinib (Team Project) December 2010
• Drafted a position paper on the sequence of processes involved in the NDA application of the anti-cancer drug- Lapatinib
• Filled out the 356h form for the NDA application of the drug.
SKILLS
Computer Skills:
• Proficient in Microsoft Office with sound knowledge about Microsoft Word, Outlook, PowerPoint, Excel and SharePoint.
• Good experience about Adobe Acrobat, BRASS system for documentation.
• Trained on using add-ons functions in Microsoft, experience with Trackwise and LotusNotes.
Communication Skills: Proven written and oral communication skills. Fluent in English.
Organizational and Management Skills:
• Collaborated with the Indian Pharmaceutical Association (IPA) and the college to develop AIDS awareness program and arranged AIDS and tuberculosis campaigns.
• Organized blood donation camps in the College Premises for Jaslok Hospital, MUMBAI.
INTERESTS
Singing, Dancing, Reading books, Music, Cooking, Cricket, Football and Athletics.
REFERENCES
Available on request.
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