Nikhil Chothani

Pharmaceutical professional with 4+ years of experience in API R&D, multi-step synthesis, Process development and optimization its characterization, technical documentation, analytical data review, and CMC data support. Experienced in supporting compilation and review of API specifications, analytical methods, stability data, impurity information, annual reports, and other CMC related data for DMF and dossier-related activities. M.Sc. in Organic Chemistry with an Advanced Postgraduate Diploma in Regulatory Affairs (API & Formulations), covering ICH guidelines, CTD/eCTD structure, DMF, CEP, ANDA, MAA, and regulatory submission requirements for US, EU, India and other markets.

Seeking to transition into Regulatory Affairs and leverage strong scientific and technical documentation expertise.

Executive - Troikaa Pharmaceuticals

(2026-07)

• Support API R&D activities involving technical documentation, analytical data review and CMC related information
• Reviewed vendor and in-house Certificates of Analysis (COAs) against applicable pharmacopoeial monographs and specifications. preparing and reviewing Product Optimization Reports (POR) and Product Development Reports (PDR), Letter of Authorization (LOA), Technical documents review and compilation.
• Supported compilation and review of API specifications, analytical methods, stability data, impurity information, Annual reports and other CMC(3.2.S) related technical information for DMF and dossier documentation.
• Coordinated with relevant cross-functional departments and quality functions to ensure completeness and consistency of technical data.
• Maintained accurate technical records in accordance with GDP and adherence to SOPs and data integrity principles, supporting error-free, audit-ready records for regulatory submission readiness.

Senior Research Associate - Syngene International Ltd.

(2022-07 - 2026-07)

• Execution of multi-step synthesis of product & its isolation, characterization by various analytical methods, adhering to desired quality standards as per requirements.
• Utilized scientific database and tools like Scifiner, Reaxys, Chemdraw along with literature & patent search using USPTO, Espacenet, Patent scope, etc. to support process optimization.
• Maintained electronic & hard copy lab notebooks in strict compliance with SOP, ALCOA+ and GxP standards to ensure error free data submission.
• Preparation & execution of given target in alignment with Product timelines and research goals.

M.Sc. - Organic Chemistry - Fergusson College, Pune, Maharashtra (2020 - 2022)

B.Sc - Chemistry - L.V.H. College, Nashik, Maharashtra (2017 - 2020)