Sha Niymath

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 · Bannur
  Sep 2024 – Jun 2026

  - Warehouse Management in Hospital – GDP, FIFO, Tracking & Monitoring, Stock control, Demand Forecasting, Receiving & Storage, Material Handling, Order Fulfilment, Safety Procedures, Documentations. - Practical Training in Casualty, OPD, Drug Store Management and Directed the Dispensing department. - Preparation, Compilation and Submission of ANDA’s - GUDFA. - Preparation of various Supplements like PAS, CBE-0, CBE-30, Source change and Stie transfer, Proficiency in ESG Submission portal, eCTD – DTD latest Version. - Review of regulatory submission documents like DMF, API, BMR, BPR, finished - products and also query response as per USFDA/ICH requirements. Acquired proficiency in Pharma Ready, Educe Software for eCTD Submission. - Oversaw for Product Life Cycle Management (PLM). - SFDA Drug registrations. - MAA, SDR, Upload product file. - Variations – Type IA, Type IB, Type II. - Renewal of Marketing Authorization Application. - SFDA – DMF, Letter of access.

• Regulatory Affairs Professional
  Strides Pharma Science Ltd. · Bangalore
  Nov 2023 – Jul 2024

  - Preparation, Compilation and Submission of ANDA’s - GUDFA. - Preparation of various Supplements like PAS, CBE-0, CBE-30, Source change and Stie transfer, Proficiency in ESG Submission portal, eCTD – DTD latest Version. - Review of regulatory submission documents like DMF, API, BMR, BPR, finished - products and also query response as per USFDA/ICH requirements. Acquired proficiency in Pharma Ready, Educe Software for eCTD Submission. - Oversaw for Product Life Cycle Management (PLM). - SFDA Drug registrations. - MAA, SDR, Upload product file. - Variations – Type IA, Type IB, Type II. - Renewal of Marketing Authorization Application. - SFDA – DMF, Letter of access.

Education

• M.Pharm
  Adichunchanagiri University · Adichunchanagiri University
  Pharmaceutical Regulatory Affairs · 2022 – 2024
• B.Pharm
  Dayananda Sagar University · Dayananda Sagar University
  Pharmacy · 2019 – 2022
• Diploma
  JSS Academy of Higher Education & Research · JSS Academy of Higher Education and Research
  Pharmacy · 2017 – 2019

Skills

• SFDA Drug registrations. MAA, SDR, Upload product file. Variations – Type IA,
• Type IB, Type II. Renewal of Marketing Authorization Application.
• US-FDA, EMA, MENA region, ICH and ISO, MOH, DHA, DOH, GCC – DR
• Lorenz software, Extedo software
• Regulatory Submission Process Module 1 to 5
• Approval Pathways for Drugs, Medical Devices and Cosmetics.
• ATC’s, QA, QC, GMP, cGMP, GLP, Dosage Form
• Informed consent, Injectables, AI/ML, Prescription to OTC
• Regulatory Affairs, GMP, GLP, cGMP, Ms Excel, Ms Word
• Ms PowerPoint, USFDA, EMA, SFDA, ICH, ISO, CTD, eCTD
• DMF, Medical Devices, UDI, MDMA, AR, MDIL, CE marking, IVD products, MDSAP
• SFDA - DMF, Letter of access, Sdr.drug@sfda.gov.sa
• PDF properties, orange book & purple book, Audit - Internal & External Audit
• PADER, PAS, Annual Report, FDA @ Drug, NDC Directory, Daily Med, USP Monograph
• Strong Interpersonal and Communication Skills
• Attitude to work with Dedication and Involvement
• Positive thinking and Adaptability to new environment
• Time management, Strong documentation & reporting ability,
• Hard working - ability to work independently & able to mange multiple projects
• Time management, Ability to work independently under pressure
• Strong analytical, Problem solving & training skills
• Strong documentation & reporting ability
• UpToDate with regulatory guidelines including registration process's
• Positive thinking, Practical patience, Think critically
• Strong adaptability to new environments and people.

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

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

⚽ 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