Arun Pawar
Regulatory Affairs Associate II at Eugia Pharma Specialities Ltd
Greater Hyderabad Area
1+ year of work experience
Aug 20263 mosOct 2026
1.Coordination with cross-functional teams, including formulation development, quality control & assurance.
2.Review and verify the accuracy and completeness of regulatory documents (AMV, COA, Nitrosamine and elemental declaration, packaging material, BMR, MFR, stability protocol, BPR, and stability data etc.) with respect to regulatory requirement.
3.Dossier preparation (Module 1, Module 2, Module 3 and Module 5).
4.Handling of Query response from agency related to Quality and timely response.
5.Preparation and compilation of Renewals and RUP for EU market.
6.Filing of Administrative, Quality and safety related variations.
Aug 20251 yr 1 moAug 2026
1.Coordination with cross-functional teams, including formulation development, quality control & assurance.
2.Review and verify the accuracy and completeness of regulatory documents (AMV, COA, Nitrosamine and elemental declaration, packaging material, BMR, MFR, stability protocol, BPR, and stability data etc.) with respect to regulatory requirement.
3.Dossier preparation (Module 1, Module 2, Module 3 and Module 5).
4.Handling of Query response from agency related to Quality and timely response.
5.Preparation and compilation of Renewals and RUP for EU market.
6.Filing of Administrative, Quality and safety related variations.
Nov 202410 mosAug 2025
Post approval Team
Arun’s AI Stack
Education
Bachelor of Pharmacy - BPharm, Advertising
Rajiv Gandhi University of Health Sciences
20184 yrs2022
Master of pharmacy, Pharmacy
Rajiv Gandhi University of Health Sciences
20222 yrs2024
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