Dynamic Regulatory Affairs Associate with expertise from TATA 1MG, adept at ensuring compliance and quality assurance in pharmaceutical submissions. Proven ability in document management and effective communication, successfully maintaining organized records and collaborating with inspectors to uphold industry standards. Proficient in data analysis and committed to regulatory excellence.
Work History
Regulatory Affairs Associate
TATA 1MG
Kolkata, West Bengal
08.2025 - Current
Reviewed regulatory submissions for compliance with guidelines and regulations.
Maintained organised records of regulatory filings and communications.
Verified documents of pharmacists and competent persons per Drug and Cosmetic Act 1945.
Assessed square footage for drug store compliance with state criteria.
Documented data in Google Forms to ensure accuracy.
Evaluated legal documents for new drug store establishment.
Communicated with drug inspector regarding compliance issues.
Conducted site visits with drug inspector to uphold standards.
Executed chemical and instrumental analysis of pharmaceutical drugs under expert supervision.
Conducted quality control testing in compliance with Indian Pharmacopoeia and GMP standards.
Analyzed common medications, including Paracetamol and Metformin Hydrochloride, across various dosage forms.
Performed assays and identification tests utilizing UV-Visible Spectrophotometry and Titrimetry.
Reviewed standard test protocols and pharmacopoeial monographs for accuracy and relevance.
Compiled detailed test reports while adhering to Good Laboratory Practices and documentation standards.
Gained insight into government analytical laboratories' roles in drug quality assurance within healthcare.
Education
B.Pharma - Pharmacy
IES Institute of Technology And Management
Bhopal, Bhopal
06-2025
Some College (No Degree) - Science (PCMB)
Assam
Dibrugarh
06-2021
Some College (No Degree) - English, Social Science, Hindi,Mathematics,Science
Assam
Margherita
05-2019
Skills
Pharmacy expertise
Document management
Regulatory compliance
Good laboratory practice (GLP)
Quality assurance
Data analysis
Problem solving
Team collaboration
Effective communication
Excel proficiency
Email communication
Certification
NPTEL BIOMEDICAL NANOTECHNOLOGY
Marketing Management-I by NPTEL
NPTEL Enhancing soft skills and personality
Accomplishments
Top 3 in class, Received scholarship in B.Pharma
Awards
GPAT 2025 Qualified, AIR 1423
NIPER 2025 Qualified, M tech AIR 791
Ms/M pharma Qualified, AIR 2153
Projects
Phytochemical Screening and Pharmacological Prospects of Makhana (Euryale ferox), 01/01/25, 05/01/25, Focused on analyzing and compiling existing scientific literature related to the nutritional value, phytochemical composition, and medicinal potential of Makhana, a traditional aquatic plant used in Ayurveda and Traditional Chinese Medicine. The review highlighted the presence of key bioactive compounds like flavonoids, alkaloids, saponins, and phenolics, which contribute to its antioxidant, antidiabetic, anti-inflammatory, and cardioprotective effects. It also emphasized Makhana's role as a functional food with growing relevance in the nutraceutical and pharmaceutical industries.