Bhagyashree Jadhav

I am a Regulatory Affairs professional with a background in organic chemistry and hands-on experience preparing CTD, ACTD and country-specific dossiers for semi-regulated and regulated markets. I focus on solid oral, injectable and suspension dosage forms.

I currently handle review of COAs and artworks, coordinate with QA teams and vendors, and follow up on regulatory queries to drive timely product registrations. I have prepared dossiers for markets including NAFDAC and supported ANDA/USFDA and EMA-related guidance.

I completed a specialized program in Drug Regulatory Affairs & Pharmacovigilance and hold certification in HPLC analysis, giving me a strong technical foundation for regulatory submissions and analytical review. I use CorelDRAW and MS Office regularly for artwork correction and documentation.

I bring systematic attention to detail, collaborative stakeholder coordination, and a solutions-oriented approach to compliance and registration challenges. I seek roles where I can continue to refine dossier strategy, regulatory submissions and quality interactions to accelerate product approvals.