Prajakta P. Buva

*** ******** *****, *** * Burlington, MA 01803

acpe9u@r.postjobfree.com

Contact: 978-***-****(Cell) 781-***-**** (Home)

Objective

Actively seeking an entry level role in Regulatory Affairs in Pharma, device or biologics setting.

Educational Qualifications

• Graduate in Regulatory Affairs for Drugs, Biologics and Devices (spring 2012)

Northeastern University, Boston MA.

• Bachelor of Pharmacy North Maharashtra University, Jalgaon, India (2003)

Regulatory/quality skills

• Comprehensive knowledge of regulatory pathways for different regulatory agencies in different

countries. (US {FDA}, Brazil, Canada, Japan and China) as well as ICH, cGMP, GXP and GLP

guidelines.

• Working knowledge of quality system regulations (ISO13485, CFR 820, CFR 211 and ISO 9001)

• Preparing for Regulatory Affairs Certification Exam (US RAC) for spring.

• Learned eCTD (v 2.0) via Webinar presentation.

Experience

Quality system co-op BD Biosciences Discovery Labware Bedford/ Woburn, MA (now Corning

Labware) 04/2011- 10/2011

• Reviewed and authorized batch records for diagnostic and research lab products (monoclonal

antibodies, cell sorters and analyzers)

• Supported complaint handling in Product Incident Reporting System for labware products.

• Engaged in animal origin product certification process and prepared animal certificates for Japan

and Singapore as per USDA requirements.

• Independently coordinated batch data sheet related updates. Uploaded, scanned and

distributed data sheets electronically.

• Actively engaged in communication with vendors and suppliers for incoming materials Quality

compliance and conformance.

• Oversaw deviations and quality notifications.

• Routinely performed delivery/shipment notifications to Japan and Europe (Temse).

• Routed, formatted and maintained Standard Operating Procedures (SOPs), procedure manuals

and material specifications.

• Effectively communicated within various departments including R&D, operations and supply

chain during routine tasks.

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Regulatory Affairs/QA Intern, Arqule Inc. Woburn, MA

04/2008-07/2008

• Controlled, organized and updated documentation of training for employees, Standard

Operating Procedures of the company, Batch Manufacturing Records, stability study

reports

• Assisted IND application preparation for FDA submission.

• Archived stability study reports and batch records.

Quality Control Analyst, Flamingo Pharmaceuticals Ltd, Mumbai India

03/2004 – 06/2005

• Managed inventory of working standards and reference standards to USP standards

• Instrument calibaration including UV spectrophotometer, Dissolution test apparatus, Karl Fisher

reagent apparatus)

• Prepared specifications and method of analysis (for tablets and capsules)

• Actively engaged in Medicines and Health care Regulatory Agency inspection documentation

preparation for compliance.

• Maintained catalog for vendor samples and communicated with vendors.

• Assisted stability studies on raw materials and finished products, prepared study reports and

maintained sample log for stability studies.

Trainee 10/ 2003 – 03/2004

• Analysis of raw materials and finished products (Ref. USP,BP)

• Prepared Standard (Normal and Molar) solutions and reagents (Ref. BP)

• Performed assays for tablets, capsules and Injections.

• Improved process for packaging material analysis.

Computer skills

Microsoft (Word, Power Point, Excel, Outlook Access) 2008, SAP, Lotus Notes 8.5 C2C training on

Quality Document Management System (QDMS), and Product Incident Reporting System(PIR) for

complaint handling.

Other

• Active member of regulatory affairs professional Society.

• Attended RAPS Boston chapter on responding to 483 warning letters on March 24th 2014.

• Volunteered for Woburn Board of Health (2013- 2014)

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