SHANIYMATH

About

I am a Pharmaceutical Regulatory Affairs professional with a strong academic background with a master's degree in Pharmaceutical Regulatory Affairs with an expectational academic record (9.02 CGPA) and a comprehensive foundation in the pharmaceutical regulatory affairs industry, and I have expertise in Drugs, Food, Nutraceuticals, Cosmetics, Dietary supplements, Medical devices - registration processes, USFDA, SFDA, Drug Registration, Submissions, Dossiers preparation, Renewal, eCTD, CTD, CMC, MAA, SDR, Upload product file, Variations – Type IA, Type IB, Type II, CBE- 0 CBE- 30, Renewal of Marketing Authorization Application, DMF, Letter of access, post & pre approval submissions, COA, LORENZ & EXTEDO Software's, Preparation, Submission of Module 1 to 5, Quality - QA, QC, SOP, ISO, QMS, Quality Operations, Internal & External Audits, CAPA, GMP, cGMP, Medical Devices, UDI, MDMA, AR, MDIL, CE marking, monitoring and improving quality standards, Data analysis, PDF properties, USFDA - post & pre approval submissions, EMA, MoPH, MOH, NHRA, CDSCO, AI-ML, registration process both regulated & emerging markets, Oral dosage, Biologics, Cosmetic regulations, Document Control & Management, Microsoft Office, SharePoint, Adobe Acrobat, Quality & regulatory compliance, Regulatory audits, Tracking, Monitoring & Management of documents, etc., - I have expertise in Preparing, reviewing, finalizing, and submitting the eCTD & CTD documents to regulatory authorities. - Product registration, labelling approval, Certifications with regulatory authorities, Product must meet the legal & quality standards, regulatory approval, tracking & monitoring. - Reviewing and evaluating the scientific documents to ensure product safety, efficacy and quality. - Communication with regulatory agencies and authorized local agents for completion of product registrations, queries handling, variations, renewals, Plant cGMP, ect., - Well versed with regulatory websites and portals. - Up to date with regulatory guidelines, laws and regulatory news with product recalls. - Role of real - world evidence in the regulatory pathway and post-marketing regulatory decisions for active surveillance of products in the market. - Maintain the regulatory and archival documents. - Planning and execution of new product registrations in the proper time cycle.

Experience

• Pharmacy In Charge & Regulatory Affairs
  CHC
  Oct 2024 – Apr 2026
• Regulatory Affairs Professional
  Strides Pharma Science Ltd.
  Nov 2023 – Jul 2024

Education

• M-Pharm
  Adichunchanagiri University
  Pharmaceutical Regulatory Affairs · 2022 – 2024
• B-Pharm
  Dayananda Sagar University
  B - Pharmacy · 2017 – 2022
• D-Pharm
  JSS Academy of Higher Education & Research
  D - Pharmacy · 2017 – 2019
• 12th
  Department of Pre-University Education
  2015 – 2017
• 10th
  Karnataka Secondary Education Examination Board
  2013 – 2014

Skills

• Regulatory Affairs
• GMP
• GLP
• cGMP
• Ms Excel
• Ms Word
• Ms Powerpoint
• Us-Fda
• Ema
• Sfda
• Ich
• Ctd
• Ectd
• Dmf
• SFDA Drug registrations. MAA, SDR, Upload product file. Variations – Type IA,
• Type II. Renewal of Marketing Authorization Application. SFDA – DMF
• Letter of access, Medical Devices

Projects

• Comparative Study for Cosmeceutical Regulations in Emerging and Regulated Markets

  Academic project on comparative regulatory frameworks for cosmeceuticals across emerging and regulated markets.

Courses & certifications

• Uro Oncology, Breast & Lung Cancer · International Association of Oncology · 2024
• NIDA Clinical Trails Network · 2024
• Advancing Generic Drug Development: Translating Science to Approval · 2024
• Understanding FDA Inspections and Data · 2024
• OTC Monograph Reform: OMOR Format and Content & Electronic Submission · 2024
• Electronic Drug Registration and Listing (eDRLS) Using CDER Direct · 2024
• Computer Teacher Training Course (CTTC) · Ikon Computers · 2017

🗣️ Languages

• English · Professional
• Hindi · Professional
• Kannada · Native
• Arabic · Basic

⚽ Extracurricular activities

• Conference Participation

  Participated in an international conference on innovation and advances in pharmaceutical sciences.

• Poster Presentation

  Certified poster presentation at Manipal Pharmaceutical Conference (MPCON)

📚 Publications

• Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine (AI/ML)-Based Software as a Medical Device (SaMD) in US · 2025
• Regulatory Guidelines for Monoclonal Antibodies & Related Products: EMA’s Standards on Development, Production, Characterization & Specifications · 2024
• Evaluation of Anti-Inflammatory Action of Syzygium Cumini Methanolic Extract by in Vitro Study · 2019

🤝 Volunteering

• NSS · Volunteer · 2018

🎯 Hobbies & interests

• Reading guidelines and books