Regulatory Affairs

PRAHARSHKUMAR SHAH, M.S.

** ******* *****, ********, ** 08205 ~ 609-***-**** ~ ****.****@*****.***

OBJECTIVE:

• Acquire a challenging position in the field of Regulatory Affairs where solid regulatory skills will

be utilized.

PROFILE:

• Thorough knowledge of FDA and ICH guidelines and of regulations governing safety reporting

and processing.

• Thorough knowledge on IND, NDA, BLA, IDE, 510(k), PMA and De Novo submission

processes as well as the Quality Assurance process and Regulatory affairs documentation.

• Basic understanding about CAPA and 21 CFR 820 focusing on risk management.

• Well versed with Electronic Common Technical Document (eCTD) format, GCP, GMP, GLP,

QSR, MDR and ICH guidelines.

• Well acquainted with regulations for human subject protection in clinical trials; 21 CFR 50,

Institutional Review Boards (IRB) and roles of IRBs; 21 CFR 56.

• Basic knowledge of Orphan Drug programs in various countries including US, Europe and Japan.

EXPERIENCE:

Regulatory Associate, Sterfil Laboratories, India April 2010-July 2011

• Assisted regulatory team in preparing product dossiers as per regulatory requirements.

• Reviewed regulatory documents to ensure completeness and accuracy of submissions.

• Worked in liaison with different departments to coordinate, facilitate and provide timelines for

submissions.

• Managed international correspondence as well as reviewed and prepared regulatory documents

for drug shipments.

• Maintained paper files of controlled documents and prepared documents and records for off –site

archival.

• Updated procedure documentation for compliance with international standards.

• Organized and participated in project status meetings.

QA Intern, Cadila Pharmaceuticals, India June 2009 – March 2010

• Processing of various R&D product samples following protocols.

• Documentation of test results as per cGMP standards.

• Assisted the QA team in the development of dossiers for registration of products.

• Facilitated seniors in conducting GMP data analysis and documentation of testing results.

OTHER EXPERIENCE:

Lead Pharmacy Technician, Medicap Pharmacy, NJ August 2013 – Present

• Working in a retail pharmacy as lead pharmacy technician.

• Assisting Pharmacists in their duties such as filling prescriptions, filing prescription and related

documents.

• Maintain all the regulatory documentation in the pharmacy such as recalls, adverse event reports

and DEA forms.

• Working in compliance with HIPPA regulations.

EDUCATION:

Master of Science in Regulatory Affairs, Northeastern University, Boston, MA April 2013

• Related Coursework: Introduction to Regulatory Affairs in United States, Regulations of Clinical

Trials Involving human subjects, Medical Device Development: A QA regulatory overview,

Biologics development: A QA regulatory overview, FD&C Act, Practical Aspects of regulatory

compliance, Medical, social and financial dimensions of Orphan drugs and Emerging medical

device markets.

Bachelor of Pharmacy, Gujarat University, India June 2010

• Related Coursework: Pharmacology, Pharmaceutics, Biochemistry, Medicinal Chemistry, and

Pharmaceutical Jurisprudence.

PROJECTS:

• Did extensive research on the Expiration dating of drugs at Undergraduate level.

• Established a regulatory plan to market a medical device in USA through various regulatory

pathways as a part of a class project.

• Prepared and presented a Regulatory development plan to launch a medical device in 22 countries

around the world as part of term project.

• Wrote a Regulatory Development Plan for a fictional drug “HiveX” as a part of a class project

including special protocol assessment request, IND submission process, NDA submission in

eCTD format etc.

• Did a project which included the 510(k) submission through e-filing in the medical device class.

ADDITIONAL INFORMATION:

• Computer skills: Expertise in MS Word, MS Excel, MS Power point, MS Project, MS Access, MS

Outlook, Adobe and Internet.

• Experienced to manage multiple tasks, keep detailed experimental protocols and records, organize

documents and materials with efficacy and accuracy, synthesize information from a variety of

sources.

• Very good understanding of scientific principles.

• Knowledge of medical terminology, human anatomy and physiology and different disease

processes.

• Strong organizational skills, detail oriented and adapt in a fast paced, changing environment.

• Ability to work unilaterally or within teams and deliver on commitments.

• Sharp observer, quick learner and reliable.

• Strong, clear and effective oral written communication skills.

• Languages: Proficient in English, Hindi and Gujarati languages.

CERTIFICATES:

• Certified Pharmacy Technician through Pharmacy Technician Certification Board (PTCB).

Contact this candidate