Quality Assurance Microsoft Office

TANMAYEE JOSHI

ACADEMICS

M.S. in Regulatory Affairs for Drugs, Biologics and Medical devices Expected Jul’ 2016

Northeastern University, Boston Current GPA 3.90

Bachelor in Pharmaceutical Sciences Aug’ 2012

Mumbai University, India

COURSE CREDITS

Knowledge of fundamentals of the drug and biologic development and regulatory processes:

FDA standards for clinical trials and nonclinical testing including - quality assurance issues, Institutional Review Board (IRB), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP); requirements for fulfillment of Investigational New Drug Application (IND), CMC (Chemistry, Manufacture and Control), Abbreviated New Drug Application (ANDA), Prescription Drug User Fee Act (PDUFA); eCTD format for regulatory submissions; filing of the Biologics License Application (BLA) with the FDA to obtain marketing approval

Proficiency in U.S. medical device development and approval requirements:

Detailed analysis of quality assurance issues; in-depth analysis and study of CDRH's reengineering initiatives and evolving investigational device exemptions, Premarket Approval (PMA) and Premarket Notification or 510(k) application process, product development protocol and review processes

European Union (EU) Compliance Process and Regulatory Affairs:

Working knowledge of healthcare regulations for medicinal products and medical devices in the EU; understanding of the roles of EU member states, institutions and Competent Authorities; study of Conformity Assessment and Quality System Requirements; EU product postmarketing requirements; pediatric, biotechnology and vaccine regulations; regulations and standard requirements for Orphan Medicinal Products

PROJECTS

Pre-510(k) regulatory submission plan, followed by a 510(k) submission for a Class II surgical device (Surgical Mesh)

Ideal Pre clinical package for an IND application; a mock IND application including- a CMC plan for IND, a pre-IND submission and requesting meeting minutes for an anti-diabetic drug

Budget proposal for a CMC Toxicological study

Design a timeline for IND application using MS project

Mock preparation of a CAPA (Corrective and Preventive Action), Validation report & Standard operating system (SOP)

INDUSTRY AFFLIATIONS

ConforMIS Inc., Bedford, MA Jul’ 2015 to Present

Regulatory Affairs - Regulatory Affairs Co-op

Assist in the review and preparation of document packages for regulatory submissions to the US and EU. This includes 510(k)s, Design Dossiers, Technical Files and Clinical Evaluation Reports

Provide essential documentation for international submissions to countries like India, Singapore and Hong Kong

Draft new or revise Standard Operating Procedures (SOPs) and Work Instructions

Provide feedback for regulatory authorization for Document Change Orders (DCOs) and Engineering Change Orders (ECOs)

Responsible for establishment registration and device listing of products

Manage and review the implementation of FDA’s Unique Device Identification (UDI) system and update the Global Unique Device Identification Database (GUDID) for the company

Participate in Internal Audits of the Quality System, preparing audit reports and performing relevant effectiveness checks for audit corrective actions (ACA)

Oversee Corrective and Preventive Action (CAPA) implementation and execution

Conduct reviews for device labeling and advertising material for compliance with submissions

Track and co-ordinate regulatory submission activities to ensure timelines and commitments are met

Piramal Enterprise Limited, Mumbai, India Jan’ 2014- Mar’ 2014

Clinical Research and Development, NCE Research – Intern

Assisted in preparation of CMC documentation for IND submissions, clinical trial documentation, writing and maintaining documents like- Sections of INDs, clinical trial applications, Annual Reports, NDAs, Investigator Brochures, Clinical Study Reports, Protocol Worksheets and Adverse Event Reports

Maintained ongoing clinical research site correspondence files and received feedback about the trial and managed records of study activity including case report and regulatory forms

Biomarker Discovery – Research Associate Jun’ 2012- Dec’ 2013

Phase II Clinical Sample Studies:

Studied and evaluated the changes observed in the enzymatic and biomarker levels in patient samples from Phase II Clinical trials and also involved in maintaining SOPs, while following GLP protocols and maintaining a record of the results for the clinical trial samples

Combination Studies for a novel drug:

Studied the effect of P276, a novel cyclin-dependent kinase inhibitor in a head and neck cancer cell line, “FaDu”, using protein and gene expression analysis coupled with radiation

Glaxo SmithKline Limited, Nasik, India.

Analytical Department – Quality Assurance & Production, Trainee Apr’ 2010- Jun’ 2010

Performed standardized biopharmaceutical assays for accelerated stability studies, and micro-encapsulation techniques

COMPUTER SKILLS

Microsoft Office, Microsoft Project and Adobe

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