BARKHAKUMARI PATEL

***** ****** **** ****** ****** FL 33543

862-***-**** ac7xdg@r.postjobfree.com

OBJECTIVE

Highly enthusiastic Regulatory Affairs Candidate, looking for challenging opportunity in the pharmaceutical industry to utilize my skills in overall success of organization and myself. SKILLS

• Regulatory Intelligence Verbal and written skills

• Keeping track of regulatory changes and interpreting its implications on the drug and medical device development and authorization process

• MS word, power point, excel and outlook, Data Management, Coral draw, Adobe

• Diligence and tendency towards pursuit of a problem till end

• recognize roles of FDA and other standard setting organizations, their perspective on drug quality and the tools they use to ensure standards.

• Recall and describe the general and specific chemistry manufacturing and control (CMC) activities and regulatory requirements related to drug development and approval.

• Identify specific guidance and interpret regulatory expectations related to CMC activities.

• Specify CMC requirements, recognize submission formats and prepare documents for submission.

• Knowledge of presenting the regulatory implications of post-approval changes, specify regulatory requirements and justify submission pathways.

• Knowledge and understanding of Regulatory submissions like IND, NDA, ANDA, BLA, PMA, IDEs, CTD, eCTD as well as 510k

• Knowledge of market exclusivity, FDAAA, FDAMA and FDASIA, CDRH’s initiatives and product development protocol and

• review processes.

• Understanding of FDA regulations for labeling, OPDP regulations, and advertising-promotional material for products.

• ICH Guidelines; cGMP, GLP, GCP, Efficient in regulation for OTC drugs.

• Knowledge of Title 21 of CFR (Parts 11,50, 56, 201, 202, 211, 212, 312, 314, 820)

• Knowledge of functions and roles of different regulatory authorities such as USFDA, Health Canada, MHRA and PMDA. EXPERIENCE

Regulatory Compliance Analyst, LEROY PHARMACY, NEWYORK, USA

• Assist with tracking and implementation of new/Amended regulatory requirement

• Engage in testing of controls/policy adherence may offer more extensive and recording educational and counselling sessions to improve patients understanding and adherence of their therapy regimen

• Assist with existing governance committees for advanced data insights, ongoing coordination at the point of care and technological tools to help patients remember to take their medication, otherwise referred to as adherence, and minimize side effects

• Act as an independent review and evaluation body to ensure that compliance issues within the organization are being appropriately evaluated, investigated and resolved

• Responds toward suspected violation of rules, regulations, policies, procedures, and standards of conduct by evaluating the initiation of investigative procedures. Develops system for uniform handling of such violations.

Medical Representative, MICRO LABS LTD, INDIA

June 2018 – August 2018

April 2014 – May 2015

• Worked with leading ophthalmologist and discussed the products and their accuracy

• Keep up to date knowledge on latest development I the field of medicine

• Organize conferences and studies data to describe new product and develop sales approach

• Used to manage projects and relationships for assigned territories

• Respond to incoming sales calls and customer-service related issues

• Achieved sales target by 40% and led to tremendous growth organization Pharmacist, JAY AMBE MEDICAL STORE, INDIA July 2013 – March 2014

• Dispensed medication according to written prescription

• Verified patient data and billing information, discovered and resolved erroneous bills that occurred due to system error

Pharmacy Intern, MAKCURE LAB LTD, INDIA NOV 2011 – Dec 2011

• Worked with department supervisors to help troubleshoot problems which were encountered with analytical methods and sample testing

• Assisted QA manager in handling out of specification (OOS) investigations, deviations, and change controls as per cGMP Regulations

• Maintained and monitored quality and compliance targets

• Support compliance manager by conducting QMS management review and following action

• Performed in process, final and operational check inspection of injectable preparations

- Quality Assurance

• Worked in teams to develop Process Flow and Control Plans

• Worked to maintain status of calibration of instruments and equipment for analytic laboratory

• Validation of analytical method as per the method validation protocol EDUCATION

MS in Drug Regulatory Affairs Long Island University, Brooklyn, USA GPA - 3.39 2016 - 2018 Bachelor of Pharmacy L.J. Institute of Pharmacy, Gujarat, India GPA - 3.50 2009 - 2013 ACTIVITIES & ACADEMIC PROJECT WORK

• IND File preparation of acetylcholinesterase inhibitor Drug to treat symptoms of Alzheimer’s disease, Dementia and intellectual impairment.

• Preparation of CAPA for lack of GMP compliance during project work

• 510(k) notification preparation for hemodialysis machine in university project

• Pharmaceutical market of Antidepressant Drugs

• Active member of Regulatory Affairs Professionals Society (RAPS)

• Poster presentation on herbal medicine for swine flu treatment in PHARMAVENTURE 2013 at L J Institute of Pharmacy, INDIA

• Second place in quiz competition at APPOCALYPS 2012 at K B Institute of Pharmacy, INDIA

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