LEENA K. PARMAR
Apt 2, Jersey City, NJ-07306. Email: email@example.com
OBJECTIVE: Seeking to obtain a drug regulatory affairs position which provides growth opportunity within the pharmaceutical/medical device company and leverage my technical skills at the same time.
M.S. in Drug Regulatory Affairs May 2012
Arnold & Marie Schwartz College of Pharmacy, LIU, Brooklyn, NY. GPA:3.8
Mechanics of preparing IND, NDA & ANDA,FDA meetings, Drug Development Process, cGMP and ICH-GCP guidelines, Regulatory Compliance Policies, Regulation of OTC drugs, Medical Devices, Cosmetics and Animal Drugs, Labeling and promotion, and Biostatics.
Bachelor of Pharmaceutical Sciences June 2009
Sinhagad College of Pharmacy, University of Pune, India. GPA: 3.7
Graduate Assistant Jan 2010 – July 2012
Higher Education Opportunity Program (HEOP), Long Island University, Brooklyn, NY
o Entering and managing student’s data on access, filing documents, assisting professor in math class, grading student’s exams etc. Assisting academic coordinator in managing the Summer Program which includes preparing and managing the calendar of events of the summer program, preparing and managing student’s rosters, absence forms, labels, evaluations, grade reports etc.
o Tutoring Mathematics, Physics and Organic and Inorganic Chemistry.
Intern Sept 2008 - Nov 2008
Zydus Cadila Healthcare Pvt. Limited, Ahmedabad, India
o Extensive training in the quality control and manufacturing department
o Performed analysis of raw materials and finished products along with documentation of the test procedures.
o Worked in several product departments including hard gelatin capsules, soft gelatin capsules, tablets, vials and injectables.
o Performed sampling for QA and Microbiology testing on raw materials and finished products.
o Maintained batch records of manufacturing and updated Annual Product Review.(details of formulation parameters)
Long Island University, Brooklyn, NY
o Preparation and presentation of Mock IND Application for initiation of Phase II trials in patients with Alzheimer’s disease: Module 1 included preparation of cover letter, general investigation plan, investigator’s brochure, investigational label etc. Also prepared IRB’s and informed consent forms.
o Preparation of mock TPP- Target Product Profile as a part of curriculum: Prepared clinical pharmacology, non-clinical toxicology and drug interaction section.
o Preparation of mock cGMP- paper as a part of curriculum: Detailed information related to GMP history, 21 CFR 210 & 211, enforcements of GMP, cGMP new dimensions etc.
o Recall strategy: Prepared mock recall strategy report in detail by identifying recall class and problem of the recall. Demonstrated the recall strategy and CAPA to prevent recall of a product in future.
Sinhagad College of Pharmacy, India
o Presented a seminar on “Method Development In HPLC” and “Iontophorosis” as a part of course work
SKILLS (LABORATORY & CLINICAL)
o Formulation development, preparation and packaging of tablets, capsules, emulsions, suspensions, gels, creams, ointments and novel drug delivery systems.
o Familiar with the Operation of Fluid Bed Dryer, Rotary Tablet Dye, USP & IP Tablet dissolution apparatus and various chemical analysis apparatus.
o Operating and data analysis of instruments including HPLC, GC, thin layer chromatography, gel permeation chromatography, UV spectrometer, IR spectroscopy, pH meter, dissolution apparatus and friabilator.
o Participate in preparation and review of departmental SOPs.
o Archival of cGMP documents.
o Comprehensive knowledge about the Drug Discovery and Development process comprising clinical studies Phase I to Phase IV.
AWARDS AND AFFILIATION:
o RAPS (Regulatory Affairs Professionals Society)
o Rho Chi Society Membership (Awarded for academic excellence) May 2011, Long Island University, NY.
o Member of the Indian Pharmaceutical Association.
o Preparing for (RAC) Regulatory Affairs Certification.
o Team player, Well organized, Motivated, Enthusiastic, Good judgment and problem solving skills, Good oral and written communication skills and Multitasking
o Operating systems: Windows 98/2000/XP/7
o Proficient in Microsoft Outlook, Office- Word, PowerPoint, and Excel.
o Software: Access, and SPSS (Statistical Package for Social Sciences Software).
REFERENCES: Available on request.