Griva Acharya
Regulatory Affairs
Ahmedabad
Summary
Experienced Associate Researcher with a demonstrated history of working in the pharmaceutical industry. Well experience in regulatory life cycle activities for US, EU, EMEA and APAC markets such as Post Approval Supplement filing and Annual report. Also have knowledge of formulation development of solid oral dosage form. Sound knowledge on review of all CMC related documents which have required for dossier compilation (i.e., Specifications, PDR, DMF, AMVR, PVR and Stability data etc.).
Overview
7
7
years of professional experience
Work History
Regulatory Consultant
SYNEOS HEALTH
07.2023 - Current
- Post Approval Regulatory Submission for US, APAC and EMEA Markets.
Senior Executive
AMNEAL PHARMACEUTICALS LTD
08.2020 - 07.2023
- Post Approval Supplement filing including Major supplement like Addition of strength, Alternate API Source and Site transfer supplement for US Market.
- Submission of Annual Report and Marketing Notification.
- Review and assessment of Change Control forms and DMF notifications.
Research Associate –I
AUROBINDO PHARMA LTD.
07.2019 - 07.2020
- Pre- Approval regulatory submission (Module 3.2.P.2 Pharmaceutical Development report) for Europe Market.
Education
M.Pharm - Pharmaceutics
Nirma University
Ahmedabad01-2019
Bachelor of Pharmacy - undefined
The Maharaja Sayajirao University of Baroda
Vadodara, Gujarat01-2017
Skills
Submission compliance management
Software proficiency in Veeva Vault Cognos and ETQ Caliber expertise MS Office suite skills Data analysis and management
regulatory documentation
Worldwide regulatory adherence
compliance documentation
Fact-checking process
File governance
Information validation
Technical authoring
stakeholder collaboration
Release management
effective team dynamics
Interests
Reading Books, Trekking, Traveling, Dancing
Accomplishments
Awarded as second prize winner for Employee of the Month for Month of April 2021 and Team of Quarter for Q2, year 2021, while working in Amneal Pharmaceuticals.
PERSONAL ACHIEVEMENTS
- Former event organizer at the national level social event called PRERNA – The emancipation, at MSU Baroda.
- Successfully completed The Everest Base Camp trek (Altitude: 5364 meters) and many other high altitude Himalayan treks.
- Professionally performed Bharathnatyam Dance in many cultural events.
Timeline
Regulatory Consultant
SYNEOS HEALTH
07.2023 - Current
Senior Executive
AMNEAL PHARMACEUTICALS LTD
08.2020 - 07.2023
Research Associate –I
AUROBINDO PHARMA LTD.
07.2019 - 07.2020
M.Pharm - Pharmaceutics
Nirma University
Bachelor of Pharmacy - undefined
The Maharaja Sayajirao University of Baroda