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Chaitanya Sonawane

M.Pharm (Pharmacology) | Regulatory Affairs Professional | Ex-Cipla Regulatory Compliance | eCTD | ICH | USFDA | MHRA | GMP/GxP |

Pune District

1+ year of work experience

Cipla
Mar 20251 yrFeb 2026

Mumbai

• Ensured compliance with regulatory standards for Regulatory Affairs and Quality Assurance in pharmaceutical processes. • Collaborated with international guidelines from ICH, WHO, and various markets including Brazil, the US, EU, and ROW. • Managed DMF filings to support product registrations and market access.
Bora Pharmaceutical Pvt. Ltd
Mar 20212 mosApr 2021

• Developed a strong understanding of scientific principles to support innovative product solutions. • Engaged in project management activities, overseeing the planning and execution of various projects. • Documented processes, experiments, and findings to ensure clarity and reproducibility in research.

Education

Master's degree, Pharmacology

Padamshri. Dr.Vitthalrao Vikhe Patil Foundations College of Pharmacy, Wadgaon Gupta, Vilad Ghat, Ahmednagar 414111

20222 yrs2024

Bachelor's degree, Pharmacy

Mula Education Societys College of Pharmacy

20184 yrs2022

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Headline

M.Pharm (Pharmacology) | Regulatory Affairs Professional | Ex-Cipla Regulatory Compliance | eCTD | ICH | USFDA | MHRA | GMP/GxP |

About

A pharmaceutical professional with a Master's degree in Pharmacology from Padamshri Dr. Vitthalrao Vikhe Patil Foundations College of Pharmacy (2024). Experienced in regulatory compliance and quality assurance from a tenure at Cipla, where they ensured adherence to global regulatory standards, including ICH, WHO, and various international markets such as the US, EU, and ROW. Proficient in regulatory documentation, DMF filings, and facilitating market access through product registrations. Authored a review article in the Journal of Chemical Health Risks on the role of herbal medicines in cancer care, showcasing skills in literature review, oncology research, and evidence-based analysis. A registered skilled pharmacist with a strong commitment to advancing drug safety and regulatory compliance.

Location

Pune District

Work experience

Regulatory Compliance at Cipla, Mar 2025 - Feb 2026 · 1 yr, Mumbai, • Ensured compliance with regulatory standards for Regulatory Affairs and Quality Assurance in pharmaceutical processes. • Collaborated with international guidelines from ICH, WHO, and various markets including Brazil, the US, EU, and ROW. • Managed DMF filings to support product registrations and market access.

Trainee Intern at Bora Pharmaceutical Pvt. Ltd, Mar 2021 - Apr 2021 · 2 mos, • Developed a strong understanding of scientific principles to support innovative product solutions. • Engaged in project management activities, overseeing the planning and execution of various projects. • Documented processes, experiments, and findings to ensure clarity and reproducibility in research.

Education

Master's degree, Pharmacology, Padamshri. Dr.Vitthalrao Vikhe Patil Foundations College of Pharmacy, Wadgaon Gupta, Vilad Ghat, Ahmednagar 414111

Bachelor's degree, Pharmacy, Mula Education Societys College of Pharmacy

Chaitanya Sonawane - Regulatory Compliance in Pune District | Tal