PRATIK DHERANGE

**** *********** ******, *** ****, CA 95132 accifv@r.postjobfree.com 408-***-****

EDUCATION

Northeastern University, Boston, MA

Candidate for Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices (GPA: 3.50) June 2014

Related Courses:

Introduction to Drug and Medical Device Regulation, Biologics Development, New Drug Development, Medical Device Development,

Regulatory Writing, Advertising and Promotion of Drugs and Medical Device Products, Global Awareness: Canada, Asian, and Latin

American Regulatory Affairs, Strategic Planning and Project Management for Regulatory Affairs.

Post Graduate Diploma in Pharmaceutical Management (GPA: 3.92), University of Mumbai, India June 2009

Bachelor of Pharmacy (GPA: 3.27), University of Mumbai, India May 2008

WORK EXPERIENCE

TRA360, Waltham, MA

Regulatory Intern June 2013 - September 2013

• Complied different sections of the technical file for client regulatory submissions.

• Reviewed regulatory documents to ensure compliance with FDA requirements, agreements and regulations.

• Provided guidance and support on regulatory submissions to life science clients as well as served as a regulatory resource for clients.

• Maintained awareness of changes in FDA requirements for effective regulatory submissions.

• Conducted market research on current and prospective customers in the life sciences and related industries.

• Served as a company representative in professional networking events and conferences.

Meridian Enterprises Pvt. Ltd., Mumbai, India October 2012 - December 2012

Executive Regulatory Affairs

• Complied and submitted regulatory submissions to regulatory agencies within established timelines.

• Provided administrative support to the regulatory processes including compilation and dispatch of regulatory submissions.

• Completed forms and requests originating from government agencies relating to product registration requirements.

• Responsible for verifying status of regulatory files, including by maintaining contact with regulatory authorities.

• Organized and tracked regulatory files, spreadsheets and updated regulatory and other support documents as needed.

Naprod Life Sciences Pvt. Ltd., Mumbai, India February 2011 - October 2012

Officer- Drug Regulatory Affairs (Dossier preparation and labeling operations-Oncology)

Prepared and submitted CTD dossiers for domestic and international markets like Asia, Africa and South America.

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Developed and maintained global templates, other guidelines, and advanced formatting for regulatory submission documents.

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Regularly interacted with various internal departments in order to communicate regulatory requirements and availability of documents.

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Organized and documented internal regulatory processes, such as internal audits, inspections, license renewals, and registrations.

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Facilitated interaction with regulatory clients, such as in meetings and conference calls, for submissions and approval process.

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Responded to questions related with regulatory submission received from clients and regulatory agencies.

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Prepared and reviewed product labels and patient information leaflets for compliance with regulatory approvals and regulations.

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Assisted in the review of advertising and promotional items.

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Researched international legislation, guidelines and customer practices in all countries that the company is exporting to and presented

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findings in bi-monthly meetings to management.

PROFESSIONAL AFFILIATION

Member of Drug Information Association (DIA)

ACADEMIC PROJECTS

• Designed an official NDA cover sheet for the USFDA to request authorization to commercialize drug product.

• Researched and drafted a paper on the processes associated with seeking FDA regulatory approval to market drug products and

presented finding to professor and classmates.

REGULATORY SKILLS

Knowledge of IND, NDA, ANDA, CTD, eCTD, cGMP, GLP, GCP, FDA and IRB regulations.

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Regulations governing Clinical Trials, ICH Guidelines, Informed consent process, and ethical issues involved in clinical trials.

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Labeling Requirements, Case Report Forms (CRFs), Serious Adverse Event reports, Change controls, MSDS.

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Premarket approval (PMA), PMA supplements, 510K, Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE).

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COMPUTER SKILLS

Proficient with Windows7/8, Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.

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