Quality Assurance Control

S nehal M ah ida

*** ******* * * ***, M a lden, MA, 02148

*************@*****.***, 312-***-****

Professional Experience

The Autism Research Foundation, Boston, Regulatory Affairs Associate M ay

2012 - Present

• Applying for the registration of a t rademark for the Foundation’s logo

• Drafting informed consent forms to be provided to clients of our inclusion programs

• Ensuring compliance with the safety guidelines and requirements for the Biosafety Level-2

l aboratories

• Researching and communicating relevant laws and regulations that govern 501(c)3(Tax Exempt)

organizations

• Investigating for Continuing Education Credit certification for the Foundation’s online references

Ravi Pharmaceuticals, Regulatory Intern M ay

2010 - March 2011

• Investigated and initiated CAPAs for testing and packaging and improved their efficiency

• Assisted in Compiling and submitting Drug Master Files (DMFs) and DMF Annual Reports

• Assisted in drafting the Annual Report

• Reviewed documents for drug shipments

• Maintained Batch Manufacturing Records

• Supported Quality Control and Quality Assurance teams

• Maintained documentation for annual audit

Skills

Academic Regulatory Skills

• Sound knowledge of FDA submission guidelines

o I ND, NDA/ANDA, BLA, CTD and eCTD, CBE, PAS, 510(k), PMA, IDE, HDE, STED, and

annual reports

• Good understanding of Informed Consent Documentation

• Research ethics in clinical t r ials

• In ternational shipment of study samples

• GLP, GMP and GCP standards, labeling regulations, advertising regulations, post-marketing

compliance

• Sound knowledge of FDA and IRB regulations

• Well versed with international drug and medical device regulations

o Canada, M iddle East, Europe, and Asia

Additional Skills

• Proficiency in Microsoft Office (Word, Excel, Outlook and PowerPoint)

• Proficiency in Adobe Acrobat

• Constantly improving English communication skills

• Excellent organizational and management skills

Education

S nehal M ah ida

181 Kennedy D r ive, M a lden, MA, 02148

*************@*****.***, 312-***-****

Northeastern University, Boston, MA

December 2012

Masters of Science in Regulatory Affairs

Gujarat University, Gujarat, India

Bachelor of Pharmacy

J une 2010

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