Achievements:
The appreciation certificate “YOU HAVE MADE IT” received for the hard work and completion of the work in short time period from CLARIS Life Sciences Ltd.
RAC (Regulatory Affairs Certification) offered by Regulatory Affairs Certification Board.
Affiliations:
RAPS – Regulatory Affairs Professional Society
AAPS – American Association of Pharmaceutical Scientists
Achievements:
The appreciation certificate “YOU HAVE MADE IT” received for the hard work and completion of the work in short time period from CLARIS Life Sciences Ltd.
RAC (Regulatory Affairs Certification) offered by Regulatory Affairs Certification Board.
Affiliations:
RAPS – Regulatory Affairs Professional Society
AAPS – American Association of Pharmaceutical Scientists
Work Experience:
MICRO LABS USA, INC. May 2019 – Present
Associate Director – Regulatory Affairs
Act as the US Regulatory and compliance leader and be responsible for the development, implementation and maintenance of regulatory strategies at various stages from product development through whole life cycle.
Manage generic product (ANDA) submission documents and communications with FDA and Micro Labs Limited, India for the development and approval of generic pharmaceutical products.
Responsible to share Regulatory intelligence to all stakeholders in the company to access the impact on the products and adapt the regulatory changes to avert business disruption.
Work closely with the VP (Vice President) and managers to ensure the compliance and completion of assigned projects and provide regulatory strategic options & recommendation to expedite the path to market as per FDA regulations.
Review all generic product submission including original submission, PAS, CBE-0, CBE-30, Post marketing requirements, Annual report, REMS (Risk Evaluation and Mitigation Strategy) etc. and maintain all communications pertaining to ANDAs in RA server.
Certificate of Pharmaceutical Product (CPP) submissions to FDA, to obtain marketing approval in the Rest of the World (ROW) market.
Plan and implement PLAIR & launch related activities for seamless distribution in US market.
Manage all state licenses for distribution in US market and provide strategic recommendations to stay in compliance with state specific regulatory requirements.
Manage specific Drug Price Transparency reporting and Drug Take Back programs.
Review drug listing and SPL related activities for current approved products and under review ANDA applications by adhering relevant labeling regulatory requirements.
Monitor and address product related quality and safety complaints under pharmacovigilance system.
Manage field alerts, product recalls, drug notifications pursuant to DQSA (Drug Quality and Security Act) with FDA.
Manage ATPs (Authorized Trading Partner) EPCIS connections, seamless data exchange and exception handling for shipped products to ATPs pursuant to DQSA.
Execute and manage Quality Agreements and Pharmacovigilance Agreements with CMOs.
Monitor and perform quality audits with vendors, distribution centers, return processors, CMOs and relevant service providers located in the US.
SUNRISE PHARMACEUTICAL, INC. December 2010 – May 2019
Manager – Regulatory Affairs and Research & Development
Prepare/Review CMC submission documents from regulatory perspective according to current eSubmission requirements for ANDA, PAS, CBE-0, CBE-30, Post marketing requirements, Annual report, etc. to meet scientific and technical requirements for acceptability and approvability by FDA.
Work closely with the CSO (Chief Scientific Officer) and associates to ensure the compliance and completion of assigned activities and provide regulatory strategic input and compliance with FDA regulations.
Work cross-functionally with analytical R&D department, QC department, QA department, Production department and sales department.
Track and report the status of the submission documents for different category filing for regulatory submissions by weekly/daily meeting with the quality units.
Stay informed with current updates on FDA website, webinars and new draft/final guidance which impact regulatory activities and filings.
Supporting product lifecycle from pre-market to post-marking phase, by preparing and reviewing submission documents in compliance with current regulatory requirements. Escalate the review findings to CSO for timely resolution.
Maintaining all regulatory documentation by regularly updating information for completeness & correctness and archiving upon FDA inspection and/or company requirement.
Preparation and review of manufacturing master batch records, packaging batch records, labeling batch records for new products. Revise the existing master batch records to meet the regulatory agency expectations.
Preparation of the Process validation protocols & reports, cleaning validation protocols & reports and stability protocols for the approved products with commercial batch size and make it ready for distribution.
Analytical testing of raw materials, packaging materials, in-process materials, finished product and stability samples using HPLC, GC, UV Spectrophotometer, FT-IR Spectrophotometer, Karl Fisher apparatus, pH meter, Dissolution apparatus, Atomic absorption spectrophotometer with troubleshooting, maintaining and calibrating all the instruments.
Testing of process validation & cleaning validation samples.
Process and report the analysis results using the instrument specific data processing software.
Preparation and execution of Installation Qualification and Operational Qualification of new laboratory instruments.
Preparation of the standard operating procedures and analytical test method for laboratory.
Well experienced in storage and documentation of controlled substances as per the in-house standard procedures.
Assisting product development department for new product development and any other work assigned by the management.
KVK-TECH, INC. May 2008 – December 2010
Scientist – Research & Development
Performing pre-formulation studies including Drug-excipient compatibility, moisture content, particle size analysis and pH solubility.
Preparation and review of analytical test method validation protocol and report for the new products for the submission of ANDA.
Preparation of the standard operating procedures for laboratory; analytical test method for raw materials, in-process materials and finished product and validation of calculation sheet for analytical testing.
Performing analytical testing of raw materials, in-process materials, finished product and stability samples using HPLC, GC, UV Spectrophotometer, FT-IR Spectrophotometer, Karl Fisher apparatus, pH meter, Dissolution apparatus, Atomic absorption spectrophotometer, Malvern and Thermal analysis with troubleshooting, maintaining and calibrating all the instruments.
Preparation and review of manufacturing master batch records, packaging batch records, labeling batch records, process validation protocols and reports, cleaning validation protocols and reports and stability protocols.
Checking of the controlled substance inventory for laboratory and manufacturing and prepare the year ending reports for the ARCOS filing to the DEA.
Preparing side by side comparison of the labeling materials and reviewing the labeling materials including container label and package insert, for the ANDA submission.
Performing brand product physico-chemical evaluation; sourcing and evaluation of the raw materials, compression machine toolings for the new formulations.
Plan and execute the trial batch for the new formulations and record in the notebook, analyze the results, and prepare the research and development report for the ANDA submission.
Documentation, set-up and operation of equipments (compression & capsule machine, Fluid bed dryer, granulator, coating pan) for new formulation experimental batches.
The work involves formulation of tablets, capsules and beads for immediate & controlled release and preparation of technical documents.
Well experienced in formulation, storage and documentation of controlled substances.
Gathering all the technical documents from various departments for the submission of ANDA applications.
TORRREL COSMETICS PVT. LTD. (India) April 2006 – August 2006
Executive – Documentation & Regulatory Affairs
Compile and maintain all the regulatory affairs documentation.
Involved in preparation of dossiers as Marketing Authorization Application (MAA) in line with regulatory requirements.
Supports all international queries raised by regulatory authorities.
Ensure submissions comply with applicable regulations and guidance documents.
Provide guidance and review of container label and product promotional material.
Interpret, execute and recommend modification to internal guidance, work instructions, procedures.
Track submissions and ensure timely filing of documents.
DHARINI MEDICAL STORE (India) January 2006 – April 2006
Registered Pharmacist
“Dharini Medical Store” is a well-reputed medical store besides with health-related market products, which dispense the life saving medicines and health related products and equipments.
Working there as a registered pharmacist and responsible for dispensing the medicines on the prescription and acknowledge the patients and customer about the health-related products and equipments.
CLARIS LIFE SCIENCES LTD. (India) May 2005 – November 2005
Officer – International Regulatory affairs
Preparing CMC (Chemistry, Manufacturing and Controls) section, Module-3 of CTD as a dossier preparation for European countries.
Assist to regulatory affairs manager in the other Modules of the dossier preparation for various products.
Support to ensure submissions comply with applicable regulations and guidance documents.
Coordinate with the Quality Assurance, Product Development and Marketing department in order to get the required documentation for the dossier preparation.
Maintain all the regulatory affairs documentation as per the internal procedure.
Involved in preparation of dossiers as Marketing Authorization Application (MAA) in line with regulatory requirements, particularly for European countries.
Solving the queries raised by regulatory authorities and promptly replying to them by gathering requested documents from the raw material suppliers as well as in-house testing results.
Volunteer Work:
Volunteer since year 2011 in BAPS Charities that harnesses the efforts and collective spirit of volunteers around the world to serve individuals, families and communities in five key areas: Community Empowerment, Educational Services, Environmental Protection & Preservation, Health & Wellness, and Humanitarian Relief.
Three times served as NSS (National Service Scheme) volunteer, as a college student that provides community service in the small villages without bias in India.
Two times volunteer for polio vaccination program handled by state government of Gujarat, India.
Briefly describe your education, any degrees, certifications, etc.
RAC (Regulatory Affairs Certification) offered by Regulatory Affairs Certification Board.
Education:
Master of Science in Industrial Pharmacy September 2006 – January 2009
Long Island University, Brooklyn, NY, USA GPA – 3.19 / 4.0
Thesis – Pharmacokinetics of Meloxicam in skin by Microdialysis technique in a rabbit model
Bachelor of Pharmacy September 2001 – May 2005
Hemchandracharya North Gujarat University, Patan, Gujarat, India GPA – 3.82 / 4.0
Thesis – Review of Cassia species (Pharmacognosy) to fulfill academic requirement. Performed experimental work to demonstrate “Antifungal activity of Cassia tora”.