DEVANG BAROT

+1-617-***-**** aca5p4@r.postjobfree.com 110 WARD STREET, ROXBURY CROSSING,

BOSTON, MA 02120

Looking for the Opportunities for Coop/Internship starting from January 2014

SKILLS

• Fair knowledge of regulatory filing, of IND, NDA, ANDA, 510(k)

• Sound knowledge of regulatory submissions, GXPs, especially Good clinical practices and regulations relating to

conduct of human clinical trials according to 21CFR 56 and 45 CFR 46.

• Clinical trial application, IRB, informed consent for clinical trials.

EDUCATION

Northeastern University - Boston, MA (Average GPA 3.5)

Candidate for Master of Science in Regulatory Affairs of drugs, biologics, and medical devices Apr

2013 – Present

Relevant Coursework: Introduction to Drug and Medical Device Regulation, Advanced writing on International

Biomedical Topics, Human Experimentation, New Drug Development.

Rajiv Gandhi University of Health Sciences- Bangalore, India

Bachelor of Pharmacy

Aug 2011

Relevant Coursework: Clinical and Hospital Pharmacy, Pharmacokinetics and Therapeutic Drug monitoring,

Pharmacology and Toxicology, Pathology, Pharmaceutical Microbiology and Biotechnology, Pharmaceutics, Medicinal

Chemistry, Pharmaceutical Analysis, Forensic Pharmacy

Board Of Examining Authority-Bangalore, India

Diploma of Pharmacy Oct

2007

Relevant Coursework: Pharmaceutics, Human Anatomy and physiology, Biochemistry and pathology, Pharmaceutical

Chemistry, Pharmacognosy, Drug store and Business management, Pharmaceutical Jurisprudence

CERTIFICATIONS AND ACHIEVEMENTS

Certification: REGISTERED PHARMACIST- INDIA

Achievements: Won the first prize in the Inter College Cricket Championship in Feb-2011-Mangalore, India

Won the Mime Competition on Drug Abusiveness in Feb 2011-Mangalore, India

WORK EXPERIENCE

Centurion Laboratories Ltd- Vadodara, India (Regulatory Affairs Coordinator)

Oct 2011-Feb 2013

• Trained on the SOP’s to perform all the roles of Regulatory Affairs Professional based on Quality Systems.

• Generated and drafted Corrective and Preventive Action (CAPA) plans.

• Worked with project team for the approval of the company's products.

• Developed regulatory pathways, which can ensure successful regulatory submissions.

• Electronically processed submission components which become core elements in rollup publishing activities for

domestic and international ANDA and marketing applications.

• Reviewed advertising/promotional materials for prescription drugs to ensure compliance with regulatory

requirements; represents Regulatory Affairs at Promotional Review Committee meetings when required.

• Establish and/or improve local processes by reviewing, providing input and/or drafting complex

departmental/cross-functional SOPs and Global procedures.

Vital Formulations Ltd – India (Manufacturing/Quality Assurance Associate)(Intern)

May 2008- Oct 2008

• Prepared for and participated in the internal / regulatory auditing for cGMPs norms.

• Prepare and manufacture components, subassemblies, and product.

• Monitored and observed of retain samples and performed Final inspection of finished goods.

• Processing of various R & D product samples following protocols, studies and/or manufacturing documentation.

• Perform inventory control as needed.

• Maintenance of batch records and documentations according to the cGMP standards.

• Updated quality policies and procedures manual and revise policies according to new standards compliance and

regulations, prepared a key master plan for quality services of the department;

Civil Hospital – Nadiad, India (Assistant Pharmacist)

Nov 2007 - April 2008

• Accepted prescriptions for filling, gathering and processing necessary information

• Provided information to customers about the uses, effects, and interactions of drugs and out of stock items.

• Unpacked, sorted, counted, and labeled incoming merchandise, including items requiring special handling or

refrigeration

• Prepared intravenous (IV) solutions and solid dosage medications for dispensing into bottles or unit dose

packaging.

DEVANG BAROT

+1-617-***-**** aca5p4@r.postjobfree.com 110 WARD STREET, ROXBURY CROSSING,

BOSTON, MA 02120

PROJECTS AT NORTHEASTERN UNIVERSITY

IND and NDA application of "Chantix" (Team Project)

October 2013

• Reviewed product specific FDA guidance documents, preclinical safety data & clinical investigation plan for

specified product, chemistry, manufacturing & control data and pre-market submission criteria for ‘Chantix’

along with form 356h.

• Drafted a position paper on the sequence of processes involved in the NDA application of Chantix.

• Filled out the 356h form for the NDA application of the drug.

ADDITIONAL SKILLS

Computer Skills:

• Proficient in Microsoft Office with sound knowledge about Microsoft Word, Outlook, PowerPoint, Excel

• Good experience about Adobe Acrobat.

Communication Skills:

• Proven written and oral communication skills. Fluent in English.

ACTIVITIES

Presentation as a part of course work on,

• Malaria – Comparative Studies in India, Africa and United States.

• Regulatory affairs development in Asian countries.

Contact this candidate