NACHIKET GAULKAR
Wardha
Summary
Exploring career opportunity with an organization that will take use of my management, technical and administrative skills to benefit mutual growth and success. I have approximately 3 years and 10 months of experience in the pharmaceutical industry, specializing in Regulatory Affairs. My expertise is primarily focused on Module 1 for the Europe market.
Overview
4
4
years of professional experience
2
2
Languages
Work History
Senior Executive
Micro Labs Limited
11.2025 - Current
- Evaluation and finalization of variation strategy (Type II/IB/IA) for proposed changes in the product information in DCP, MRP, UK National submissions.
- Evaluation and finalization of variation safety Variation/ Artwork/ Renewal/ Administrative for Europe Market.
- Evaluation and finalization of Module 1
- Evaluation and finalization of cover letter/eAF/SmPC,PIL, Interpack & mockup.
- Safety Variation: Evaluation and finalization of Product information update UK National
- Evaluation and finalization of Product information update Ireland National
- Evaluation and finalization of Product information update German National
- Evaluation and finalization of Product information update Spain National
- Evaluation and finalization of Product information update Austria National
- Evaluation and finalization of Product information update Netherland National
- Product information comparison with different reference products for identification and evaluations of changes.
- PRAC recommendation finalization of variation strategy Type IB/IAIN.
- If reference products withdrawn from our DCP/National Procedure I can finalized which reference products we have use.
- Evaluation and finalization of Artical61(3) Notification
- Evaluation and finalization of Bromo submission.
- In Type II Product Information Query evaluation and finalization PVAR & FVAR
- Query evaluation such RFI/VCR I can finalization of the responses for the submitted variations.
- Evaluation and finalization of renewal short end for UK National + DCP.
- Evaluation and finalization of renewal long end for UK National + DCP.
- Evaluation and finalization of ectd #seq.
- Evaluation and finalization of Article 61(3) submission.
- MHRA/CESP submission
- Artwork for Europe Market: Recently I have completed a MHRA UK Only Project.
- Artwork finalization & signed for commercial UK, Ireland, Netherland. Spain, Sweden & German Market (leaflet/carton/blister)
- Evaluation and finalization of PIQU submission in MHRA.
- Evaluation and finalization of Bromo submission in MHRA.
Executive
Micro Labs Limited
07.2023 - 10.2025
- Safety Variation for Australia (TGA) Market & New Zealand (Med safe) Market.
- Variation tracker entry and archival in the database.
- Email circulation of variation submission & approval.
- Professional achievement: I have submitted a 25-safety variation in 25 day & all get approved by agency.
- I have submitted & approved 110 product bulk UK only bromo submission.
Intas Pharmaceutical Limited
08.2022 - 07.2023
- Evaluation and finalization of variation strategy (Type II/IB/IA) for proposed changes in the product information in DCP, UK National submissions.
- Product information comparison with different reference products for identification and evaluations of changes.
- Implementation of the PRAC recommendation in the product information.
- Query evaluation and finalization of the responses for the submitted variations.
- Communication with cross functional team for Pharmacovigilance and Clinical team.
- Variation tracker entry and archival in the database.
- Variation and final product information approval circulation.
- Aware about the CTD structure and requirements.
Education
MBA - International business management
Dr. D. Y. Patil Vidyapeeth
Pune01.2025
B. Pharm. - undefined
Agnihotri College of Pharmacy
Wardha01.2022
D. Pharm. - undefined
Agnihotri Institute of Pharmacy
Wardha01.2019
12th (HSC) - undefined
SVM COLLEGE
Wardha01.2017
10th (SSC) - undefined
Agragami High School
Wardha01.2015
Skills
MS-Word, Excel, Power-point and Outlook
Interests
Reading Books, Playing Archery, Cricket, Chess
Timeline
Senior Executive
Micro Labs Limited
11.2025 - Current
Executive
Micro Labs Limited
07.2023 - 10.2025
Intas Pharmaceutical Limited
08.2022 - 07.2023
B. Pharm. - undefined
Agnihotri College of Pharmacy
D. Pharm. - undefined
Agnihotri Institute of Pharmacy
12th (HSC) - undefined
SVM COLLEGE
10th (SSC) - undefined
Agragami High School
MBA - International business management
Dr. D. Y. Patil Vidyapeeth