MS-CIT held by Maharashtra State Board of Technical Education, Mumbai Maharashtra board of vocational Examination with 8650 %
Sunita R. Karankal (Sunita Ingale)
Regulatory Affairs
Santacruz East
Summary
Distinguished Regulatory Affairs Executive with four years of experience in the pharmaceutical sector, specializing in global regulatory strategies and compliance. Proven expertise in navigating complex regulatory landscapes and ensuring adherence to industry standards while driving product development and market access. Adept at fostering cross-functional collaboration to streamline processes and enhance operational efficiency. Committed to leveraging regulatory knowledge to support innovative solutions that align with organizational goals and meet regulatory requirements.
Overview
1
1
Language
6
6
Certificates
20
20
years of professional experience
Work History
Executive Regulatory affairs
Shreya life sciences Pvt. Ltd.
01.2024 - 06.2024
- To prepare Dossier for ROW market (Uzbekistan and Russia other cis country)
- To prepare the COAs of the product.
- Follow up with the factory, clients.
- To communicate with factory for documents and samples etc
- To communicate with country head for registration of products.
- Follow ups with factory, country head, QC, QA, RA dept, also production department.
Executive Regulatory affairs
ZievaFarm Pvt Ltd
01.2023 - 12.2023
- To prepare Dossier for ROW market (Uzbekistan and other cis country)
- Liquid, Syrups, Tablets, Capsules and injectables.
- Follow up with the factory, clients.
- To file the variation, post approval changes
- To communicate with factory for documents and samples etc
- To communicate with country head for registration of products.
- Follow ups with factory, country head, QC, QA, RA dept, also production dept.
- To check labels, Leaflets, Cartons etc as per the standards and approve them for production.
- To file the final and Approved shade cards of Art Work.
- Follow up with the Art work, packaging materials with the approved manufacturer and suppliers.
- To arrange the meetings with clients and take the follow-up
Executive Regulatory affairs
Devlife corporation
02.2019 - 03.2019
- Market handled :-Asian ,South Africa
- To prepare Dossier for ROW market
- To check the Art work for the the formulated products.
- Liquid, Syrups, Tablets, Capsules and injectables.
- To prepare the COAs of the product.
- Follow up with the factory.
- Given the training for art work checking
- Maintaining the training records
- Maintaining the database
Regulatory Affairs Executive
Lupin Ltd. Head Office, Mumbai
10.2008 - 09.2010
- To prepare The Drug Master file of the APIs For US and European market, TGA as per CTD format.
- To respond to the queries from FDA and USFDA etc.
- To carry out internal audits of the company and to review the documents, batch manufacturing records, change controls etc.
- E-filing (eCTD) of the APIs.
- To Handle the customer complaints and communications.
- To prepare ACTD for MHRA(United kingdom) market.
- To maintain Database.
QA Officer
M/s. Sekhsaria chemicals ltd. Dombivli MNC Watson pharmaceuticals
12.2006 - 10.2008
- To Issue Batch Manufacturing Records and to review the same.
- To prepare Specifications and SOPs of finished, raw and packing materials.
- To Prepare and maintain the Training Records.
- To assist in QA documentation & activities(MFR of product, Process/Cleaning/Equipment Validtions, )
- To maintain and to see the Dispatch of the finished product .
- To Handle the customer complaints and communications.
- To take a QA round and to maintain Internal Quality audit records.
- Worked at Watsons formulation plant (K-7) as Quality Assurance and regulatory affairs officer.
- M/s. Sekhsaria chemicals ltd. is a well-known in pharmaceutical & chemical industry which manufactures bulk drug & specialty chemicals. and formulation at Ambernath site.
Microbiologist/QC Chemist cum QA Officer & Regulatory affairs Officer
M/s. Herbert Brown Pharmaceutical & Research Laboratories, Dombivli
11.2004 - 10.2006
- To prepare Drug Master File of product us & Europe Market
- To prepare Specifications and Analytical Protocol of finished, raw and packing materials.
- Prepared specifications and analytical protocols for finished, raw, and packing materials, ensuring compliance with regulatory standards.
- To assist in QA documentation &RA documentation (MFR of product, Analytical/Cleaning/Equipment Validtions, Stability Data
- To assist in QA documentation &RA documentation (MFR of product, Analytical/Cleaning/Equipment Validations, Stability Data
- Developed drug master file for product in US and Europe markets, facilitating regulatory submissions and approvals.
- To analyse sample of various chemical raw materials.
- Assisted with project work on CLORODIZOPAM (CDP) and METRONIDAZOLE in the analytical development laboratory.
- Acharya Group is a well-known in pharmaceutical & chemical industry which manufactures bulk drug & specialty chemicals
Education
M. Sc. - Bio-Chemistry
N.M. University
Jalgaon03-2002
B. Sc. - Chemistry
N.M. University
Jalgaon03-1999
Skills
Regulatory affairs certification
Drug regulatory affairs
Dossier preparation
COA preparation
Regulatory submissions
Regulatory affairs PGDRA
Software
Complited computer programming course from Aptech Computer Institute, Bhusawal with 6500 %
Windows 98/2000/XP,
Application MS-Office, Internet Browsing
Spectra ERP System (Quality Management for inventory control
Certification
MS-CIT held by Maharashtra State Board of Technical Education, Mumbai Maharashtra board of vocational Examination with 86.50 %
Timeline
Executive Regulatory affairs
Shreya life sciences Pvt. Ltd.
01.2024 - 06.2024
Executive Regulatory affairs
ZievaFarm Pvt Ltd
01.2023 - 12.2023
Executive Regulatory affairs
Devlife corporation
02.2019 - 03.2019
Regulatory Affairs Executive
Lupin Ltd. Head Office, Mumbai
10.2008 - 09.2010
QA Officer
M/s. Sekhsaria chemicals ltd. Dombivli MNC Watson pharmaceuticals
12.2006 - 10.2008
Microbiologist/QC Chemist cum QA Officer & Regulatory affairs Officer
M/s. Herbert Brown Pharmaceutical & Research Laboratories, Dombivli
11.2004 - 10.2006
B. Sc. - Chemistry
N.M. University
M. Sc. - Bio-Chemistry
N.M. University
Extra-Curricular Activities
Participated in science exhibition held by Symbiosis student association, School of life sciences and environmental sciences, on Science Day held at NMT, Jalgaon Poster & Working Model ,oral Presentation in the year 2001-2002. Participated in one day seminar on Keep Our Environment Clean & Greenheld by National Environmental Awareness Campaign (2000-2001) at School of life sciences NMU Jalgaon. Participated in science exhibition held by Symbiosis student association, School of life sciences and environmental sciences, on Science Day held at NMT, Jalgaon Poster & Working Model ,oral Presentation in the year 2001-2002. Participated in one day seminar on Keep Our Environment Clean & Greenheld by National Environmental Awareness Campaign (2000-2001) at School of life sciences NMU Jalgaon.
Personal Details
English, Marathi, Hindi.