Mahesh Ahire
Junior Executive @Bharat Biotech
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WORK HISTORY
Junior Executive @Bharat Biotech
Hyderabad, IN
Regulatory Affairs professional with 2+ years of hands-on experience in Indian and global regulatory submissions, clinical trial applications, and pharmacovigilance support. Strong working knowledge of NDCT Rules, CDSCO guidelines, SUGAM portal submissions (CTA/iCTA), CTRI registrations, and Health Authority interactions. Proven ability to manage timelines, prepare high quality regulatory documentation, and collaborate with global sponsors and cross functional teams across time zones.
EDUCATION
National Institute of Pharmaceutical Education and Research
M.S. PHARM, Pharmacology and Toxicology
North Maharashtra University, Jalgaon
Bachleor of Pharmacy, Science
MSBTE
Diploma of pharmacy , Pharmacy
ABOUT MAHESH AHIRE
Pharmacology & Toxicology postgraduate from NIPER Hajipur with research experience at RMRIMS (ICMR), focusing on hypertension and vascular dementia. Skilled in pharmacovigilance through my role at Elite Safety Sciences, where I supported United Therapeutics Corporation’s Remodulin safety operations with MedDRA coding, narrative writing, Argus Safety, and global compliance.I also bring 2+ years of Regulatory Affairs experience, with expertise in NDCT Rules, CDSCO guidelines, SUGAM portal submissions, CTRI registrations, and Health Authority interactions. Proven ability to manage timelines, deliver high-quality regulatory documentation, and collaborate effectively with global sponsors and cross-functional teams. Passionate about drug safety, regulatory compliance, and advancing healthcare through precision and innovation.
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