Regulatory Affairs & Drug Policy


●CDSCO Certification – PharmaState Academy
●Drug Regulatory Affairs Certification – PharmaState Academy
●Patent Drafting for Beginners – NPTEL
●Introduction to Professional Scientific Communication – NPTEL
●Good Clinical Practice (GCP) – NIDA Clinical Trials Network
●Scientific Writing in Health Research – ICMR NIE
●Ethics Review in Health Research - ICMR NIE
●e-based Advanced Training and Certification Program in Pharmacovigilance - Digno Tech Lifesciences pvt. Ltd.
●Employability skill training program- Mahendra Pride Classroom
●Soft Skills Training – IIT Madras
●MSCIT
●M.Pharm (Pharmaceutics) postgraduate with a strong focus on Regulatory Affairs, supported by robust expertise in formulation development, drug delivery systems (NDDS), and pharmaceutical analysis. Well-versed in regulatory documentation, CTD/eCTD basics, ICH and CDSCO guidelines, GMP compliance, and quality assurance, with the ability to align product development with regulatory requirements.
●Demonstrated research capability through projects on nanoemulgel (transdermal delivery), CAR-T Cell Therapy, and BioMEMS (poster presented at Indian Pharmaceutical Congress 73rd edition), along with consistent innovation achievements including Avishkar 2024 District-Level Winner and Avishkar 2022 recognition. Actively engaged in national-level conferences, scientific competitions, and technical presentations, reflecting strong analytical and problem-solving ability.
●Proven leadership and communication skills through roles as NSS volunteer, NAAC representative, college fest coordinator, and event Anchor, complemented by certifications in Drug Regulatory Affairs, GCP, CDSCO, patent drafting, scientific writing, and research ethics. Recognized for a proactive learning mindset, adaptability, and the ability to deliver compliant, research-driven, and industry-relevant pharmaceutical solutions.
1. Developed an optimized nanoemulgel-based transdermal drug delivery system (TDDS) incorporating selected phytoconstituents to enhance bioavailability, skin permeation, and therapeutic efficacy. The formulation was designed for sustained and prolonged drug release with improved local action.
●Applied high-energy homogenization for nanoemulgel preparation and utilized Design-Expert software with ANOVA for systematic formulation optimization.
●Evaluated key parameters including particle size, zeta potential, physical characteristics, spreadability, and stability, confirming improved formulation stability, penetration, and controlled drug release.
2. Executed an in-depth review of CAR-T cell therapy focusing on end-to-end manufacturing (T-cell isolation, genetic engineering, ex-vivo expansion) and targeted delivery for cancer treatment.
●Winner – Avishkar 2024 (District Level): In-Situ Gel Tablets (Innovation & Research Excellence)
●Poster Presentation: Indian Pharmaceutical Congress 73rd edition (BioMEMS in drug delivery & diagnostics)
●1st Prize – Pharmacovigilance Week Poster (2024)
●Academic Performance: CGPA 8.23 (Consistent performer with practical exposure)
●Leadership Recognition: Ladies Representative (2 terms), Event Coordinator, Public Speaker (NSS)
●College Representation: University-level Debate (2 consecutive years) in University Youth Festival
●2nd Prize : Essay Writing Competition (District Level)
●3rd Prize: Essay Writing Competition (Taluka Level)
Regulatory Affairs & Drug Policy
Pharmaceutical Research & Innovation
Scientific & Regulatory Writing
Public Speaking & Knowledge Sharing
Healthcare Consulting & Strategy
Market Research and Management
Public Speaking & Presentation
Literature Review & Research Synthesis
Patent Drafting Basics
Cross-functional Collaboration
Leadership & Team Coordination
Scientific Writing & Technical Communication
Research Data Analysis and interpretation
Regulatory Affairs (CDSCO, ICH, GMP)
Pharmaceutical Formulation Development (NDDS)
Pharmacovigilance: Drug Safety Fundamentals (MedDRA, Case Processing, ADR Reporting)
Pharmaceutical Sciences