SHALAV KELA

***, ******* ******, ** #*

Jersey City, NJ 07306

+1-551-***-****

acy8qu@r.postjobfree.com

SUMMARY:

* ***** ** ********** ** Regulatory Affairs Department.

Compiled and submitted dossier application to US-FDA and for other semi-regulated countries.

Handling complete response/queries received from various drug regulatory authorities.

Reviewing and archival of technical documents

Prepared mock IND in-line with the requirements of 21 CFR 312 during MS at Long Island University.

PROFESSIONAL EXPERIENCES

Regulatory Affairs Intern, Accord Healthcare Inc., Durham, USA, May 2016 – Sept 2016

Assist in the review of regulatory documents and submissions for ANDAs, Annual Reports and Change Supplements such as CBEs, CBE-20 and Prior Approval Supplements.

Compile, Organize and archive regulatory event summaries

Assist in the documentation and transmission of product complaints, adverse event reports to appropriate recipients within the company.

Participate in the review and updating Standard Operating Procedures related to Regulatory, Quality and Pharmacovigilance functions.

Senior Research Associate, Intas Pharmaceuticals Limited, Ahmedabad, India, May 2011 – July 2015

Regulated Market – United States and Canada

Reviewed, compiled and submitted of Abbreviated New Drug Application (ANDA) and Abbreviated New Drug Submission (ANDS) in eCTD format.

Submitted 5 ANDA Dossiers with inclusion of 1 First to File for US-FDA

Submitted 3 ANDS Dossier for Health Canada

Handled US FDA queries related to Chemistry, Manufacturing and Control and Labeling.

Post Approval Supplements filling like Change Being Effected (CBE 0 and CBE 30), Prior Approval Supplements (PAS) and Annual reports.

Handled labeling revision based on innovator’s revision for commercial products.

Handled product site transfer activities related to regulatory requirements.

Prepared for external inspection of US-FDA

Semi Regulated Market – Africa, Middle East and Sri-Lanka

Evaluation of new product feasibility as per the respective market requirement.

Planning, execution and submission of new dossier, post approval variation and renewal for Africa and Middle East Countries as per the CTD guidelines.

Evaluation and submission of response to Queries/Deficiencies raised by Customers/Regulatory Authorities/Agents within timeline.

Initiation of the bioequivalence related activity.

Additional Responsibilities

Management of Product Life Cycle.

Initiation and review of drug product artworks like Package Insert, Package Information Leaflets, Medication Guide, Labels and Cartons.

Review of technical documents received from various departments such as Pharmaceutical development report (PDR), Batch Manufacturing Records, Process Validation Protocol and Report, Specification, Analytical Method Validation Protocol and Report and Stability Reports for compliance with regulatory requirement.

Archival of technical documents received from various departments.

Coordination between manufacturing facilities for the finished samples requirement of submission in all the rest of world countries as per the specific requirement of respective countries.

Responsible for transfer the registration details of respective products to manufacturing unit for meet the commercial requirement.

Liaison with various departments like F&D, Analytical Development, QC, QA, Production, stability and Corporate affairs.

EDUCATION:

Masters of Science, Drug Regulatory Affairs, Expected Graduation Date: May 2017 GPA - 3.88/4.0

Long Island University, Arnold & Marie Schwatrz College of Pharmacy and Health Sciences Brooklyn, NY.

Master of Pharmacy, Pharmaceutical Analysis, Nov 2011 GPA - 3.5/4.0

Nirma University, Institute of Pharmacy, Ahmedabad, India,

Bachelors of Pharmacy, Pharmacy, May 2009 GPA - 3.0/4.0

Sinhgad College of Pharmacy, University of Pune, Pune, India

Appearing for RAC (US) Spring 2017

ACADEMIC PROJECTS:

Presented mock Target Product Profile for ACTOS

Planned and presented Corrective and Preventive Action Plan for the mock warning letter by following 21 CFR 210 and 21 CFR 211

PRESENTATIONS

“Stability Indicating HPTLC Assay Method for Determination of Irbesartan in Pharmaceutical Formulation” Poster presentation at 62nd Indian Pharmaceutical Congress, Manipal University. Dec 2010.

“Examination of Data Integrity Issues in 2015-16 FDA Warning Letter” Poster presentation at 2016 American Association of Pharmaceutical Scientists, Annual Meeting and Exposition, Denver, USA, November 2016.

AWARDS / HONOURS

Earned outstanding scholastic achievement award and got selected into the Beta Theta Chapter of Rho Chi Society at Long Island University, New York, USA, Sept 2015 – May 2017

TECHNICAL SKILLS:

Extensive knowledge of Microsoft Office and Adobe Acrobat Software

SAP

Pharmaready – For submission of dossier in eCTD format

OASIS – For initiating dissolution studies

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