Regulatory Affairs

PRANAV D. DABEER

Matawan, NJ, 240-***-**** ************@*****.***

SUMMARY

Thorough understanding and working knowledge of 21CFR 211, 21CFR 201 and 21 CFR 314.

Basic understanding of 21CFR 320, 21CFR 820, 21CFR 812 and 21CFR 814.

Experience of editing, formatting, importing, publishing, linking, bookmarking pharmaceutical CMC documents so that they comply with standards and regulations.

Proficient in different publishing tools and validation programs (eCTD office, ISI Toolbox, Adobe Acrobat Professional, LORENZ eValidator)

Expert in compiling Annual reports, DMFs, updates/labeling updates/ Amendments (ANDAs).

Coordinate with Quality Assurance, Scientific affairs, Operations, Marketing, Technical team and Analytical lab personnel for ANDA submissions and DMFs of APIs.

Expert experience of BMR, SOP preparation and review.

Exceptional academic background in Pharmaceutical Marketing, Pharmaceutical Sciences, Regulatory Affairs, Statistics, Public health, Health policy.

Expert knowledge of manufacturing processes including distillation, filtration, chromatography, lyophilazation.

WORK EXPERIENCE

Regulatory Affairs Associate Apicore US LLC, New Jersey, US May 2013 to Present

Worked under the RA Director in preparing and evaluating the ANDAs to ensure their completeness.

Prepared and reviewed the submission of Annual Reports and DMFs to FDA in CTD format.

Coordinated and worked with authors to make sure all documents met their requirements.

Responded to deficiencies and questions related to DMFs and Annual Report submissions.

Coordinated with other team members for developing and implementation of the SOPs.

Examined and compiled the Labeling, Advertising and Promotional materials with Regulatory Compliance.

Uploaded finalized documents into EDMS to create final submission copy and submit through ESG to FDA.

Compiled and reviewed quality agreements and vendor qualification for Contract manufacturers and vendors.

Validated the submission to ensure compliance to 21 CFR.

Production Supervisor Apicore, LLC, New Jersey, US May 2012-April 2013

Supervised production facility in an API manufacturing facility.

Maintained work flow by monitoring steps of the process; setting processing variables; observing control points and equipment.

Monitored personnel and resources.

Implemented cost reductions, developed reporting procedures and systems.

Facilitated corrections to malfunctions.

INTERNSHIPS

GlaxoSmithKline, Nasik, India June 2011 – Aug 2011

Industrial Training

Assisted in the preparation of CMC section of regulatory submissions (module 3)

Retrieved regulatory guidance documents for CDSCO, FDA and EU and updated flowcharts and SOPs for Manufacturing Quality Process

Reviewed change control documentation as it pertains to reportable changes to Central Drugs Standard Control Organization(CDSCO) and FDA

Marketing Intern – Koral Pharma Pvt. Ltd, Nasik, India Aug. 2009 - Dec. 2009

Worked on strategic marketing and advertising strategies for the current line of products, content development for the website.

Market Research Project - Curie Manavta Cancer Center, Nasik, India June 2011 – Aug 2011

Project: ‘Current trends in prescribing Anti-cancer Drugs' in one of the South Asia's Largest Cancer Care Network `HCG’. Use of questionnaires to collect patient data to find out current trends in the anticancer products in the selected geographical area- Data analysis- Extensive use of SAS/GRAPH, SAS/BASE, SAS/STAT

EDUCATION

Master of Science, Pharmacy Administration

University of the Sciences, Philadelphia, PA May 2012

Bachelor of Science, Pharmacy,

University of Pune, India May 2010

TECHNICAL SKILLS

Microsoft Office, eCTD office, ISI-writer, ISI-toolbox, LORENZ eValidator, Adobe Acrobat Pro, SAS Basic, Qumas.

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