Regulatory Affairs

Vani Sindwani

**** ******* ***** **, ***********, MA, 01581 ****.********@*****.*** Ph. 508-***-****

Highly skilled and self motivated regulatory affairs professional with extensive knowledge of US FDA and International Regulatory Approval Process. Comprehensive understanding about medical device and drug regulations, proficient in regulatory submissions including 510(k), PMA, IND, NDA along with fluency in GMP’s and Quality Systems. Thorough understanding of product development process. Proven ability to work in cross functional teams and handling multiple projects. Strong oral and written communication skills. Acquired project management skills through MBA in Pharmaceutical Management.

EDUCATION

Candidate for Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Northeastern University, Boston, MA Sep 2010 - Dec 2011

Recipient of International Regulatory Affairs Student Scholarship at Northeastern University

MBA in Health, Hospital and Pharmaceutical Management (Gold Medalist)

Institute for Health Management and Research, Jaipur, India May 2006 - Jan 2008

Bachelors in Pharmacy

Guru Jambeshwar University, Haryana, India May 2002 - May 2006

CORE COMPETENCIES

Medical Devices:

• Extensive knowledge about the regulatory bodies, and approval process for medical products in US, Europe, Japan

• Quality Systems (21 CFR 820, ISO 13485, Q10, cGMP for combination products) in Medical device industry

• Substantial knowledge about premarket submissions including 510(k), PMA, PMA supplements, annual reporting requirements, medical device reporting and complaint handling

• Ability to retrieve information, compile and organize submission documents

• Adept in preparing SOPs, working with changing business procedures and managing CAPA and procedures for managing changes to the existing product / procedure

Drugs / Biologics / Clinical Trials:

• Regulatory submissions: IND, NDA, BLA , OTC submission

• Well versed with the post marketing requirements, adverse event reporting, annual reports and supplement submission

• Informed consent forms including waiver requirements, IRB memos, FDA warning letter responses, site inspection preparation

• Profound understanding of FDA regulations, guidance documents, CFR, review process, clinical trial applications (CTA), clinical study protocols, IRB requirements and case report forms

• Assessment of the patient recruitment criteria and drafting protocols for Phase I, II and III clinical studies

• Knowledge about regulatory process and labeling requirements for orphan, OTC and prescription drugs US and EU Directives

• Ability to maintain/track the regulatory documents and provide assistance for compiling annual reports, supplements and other supporting documents or files

PROFESSIONAL EXPERIENCE

Northeastern University, Boston Sep 2010 - Present

Proctor, Residential Safety Office

Evalueserve (www.evalueserve.com) Jun 2008 - Dec 2008

Conducted primary and secondary research, competitive intelligence, translated business requirements into specifications, communicated with the clients, analyzed and drafted business reports

PharmArc Analytical Solutions (www.pharmarc.com) Jan 2008 - May 2008

Performed disease prevalence studies and calculated the disease incidence forecasts for populations at risk; using Microsoft excel

Win Medicare Private Limited Mar 2007 - May 2007

Specialized in conducting primary research and data analysis

Laborate Labs May 2005 - July 2005

Worked as an intern in Quality Control department; assisted QA professional in quality checks and documentation

SKILLS

• Regulatory Skills - FDA Guidances and procedures, detailed knowledge about CFR’s, FDA and EMA regulations, knowledge of eCTD format, GMP and GCP Compliance

• Computer Skills - Expertise in Microsoft Word, Microsoft Power Point, Microsoft Excel

ACHIEVEMENTS AND ACTIVITIES

• Recipient of International Regulatory Affairs Student Scholarship at Northeastern University

• Received “Gold Medal” for excellence in academics during MBA

• Represented as a Placement Representative in college career fairs

• Organized cultural festivals and won various prizes in debates, speech, extempore and dance competitions

• Member of NEU Regulatory Journal Club

• Preparing for RAC (Regulatory Affairs Certification)

References available upon request

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