Avinash Bachhil

About Avinash Bachhil

Submission Management for various EU/US submissions along with the development and implementation of the regulatory strategies for Pharmaceuticals and drug-device combination products.2. CMC Writing & Review, CTD filling (Paper filling), eCTD filling (electronic submission), devising Regulatory Strategies, Document Management System, SOP & workflow writing and Review, Regulatory Compliance, Regulatory Liasion, Pharmacopeial Compliance Initiatives & People Management.3. Expertise in dossier preparation & updating of registration dossiers in E-CTD format using Insight Publisher, eCTD Xpress, ISI Publisher and PharmaReady®, SPL R4 preparation.4. Good working knowledge of the Regulatory requirements in terms of the document level, and submission strategy for Pharmaceuticals & Medical Devices.5. Proficiency in application of regulatory guidelines in the development, analysis and manufacture of product.6. Co-ordination with internal supporting departments /Line functions to prepare Dossiers.7. Expertise in evaluating the scenarios of Technical validation issues and rectification of the same briskly.8. Compiling, Review and Filing of dossiers for product registration & Organization registration.9. Responding to Regulatory Agencies’ queries on submissions / filings.10. Review of COAs, Validation Protocols, Stability data, Specifications.11. Reviewing of documents related to license, GMP and COPP applications for various sites.12. Regulatory inputs, Gap Analysis and Review of product development, setting specifications, validations, stability, etc. Special focus on US & Europe market.13. Preparation of registration checklists.14. Maintaining of registration status- Annual Reports, Renewals, etc.Specialties: NDA, ANDA, PIV Filing, E- Submissions for various Regulatory Submissions, Query Management, Proficiency in application of regulatory guidelines in the development, analysis and manufacture of product.

Experience

1. Executive Director - Portfolio Optimisation & Hub Operations Global Raapv Organon R & d

   Organon

   Jan 2024 — Present

Education

• The ICFAI University, Tripura

  Master of Business Administration - MBA, International Business

• Meerut Institute Of Engineering & Technology

  2006 B. Pharma(Hons, Pharmacy

  2002 — 2006

• The ICFAI University, Tripura

  Master of Business Administration - MBA, Innovation Management

• L.M. College Of Science & Technology, Jodhpur (Rajasthan)

  M.Pharm., Pharmaceutical Regulatory Affairs

  2006 — 2008