Mitalee Waghmare

About Mitalee Waghmare

Mitalee W••••••••@gmail.comEMINENT PHARMACEUTICAL REGULATORY AFFAIRS SPECIALIST• Proactively contribute to shape regulatory environment and act as link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.• Diligent attention to provide regulatory support for product applications and submissions for effective and successful implementation of regulatory strategies. • Quality Assurance management roles, including voice of customer activities, validation and commercialization.CORE COMPETENCIESRegistration and Re-registration of Drug Products – EU eCTD dossier Compilation and Variation Filling-Pre approval & Post approval Activities of Drug Substance – Handling Product Related Regulatory authority & Customers Deficiencies – Maintain Lifecycle of eCTD Submissions-QbD Implementation - QA Coordinator - IPQA & Documentation (Change Control, Deviation, OOS/OOT, CAPA, Reprocessing & Reworking, Returned Goods)- GMP Compliance & Regulatory Audit Preparations.

Experience

1. Regulatory Affairs Executive at Disphar International Bv

   Disphar International Bv

   Oct 2017 — Present · Mumbai, IN

   Initial registration of Drug products in EU (Via DCP, MRP/RUP, NP procedure) & ROWmarket: Compilation and preparation of registration dossiers in CTD format as per theregistration guidelines of the health authority. Handling of deficiencies received from Regulatory authorities and customers: Furnishingthe scientific responses to deficiencies received from various regulatory authorities andcustomers. Post-registration activities: Preparation and Submission of post-registration variations(Administrative, Quality, Safety (Type IA/IAIN, IB & II, Article 5-Single or grouping) andArticle 61(3) notifications) to the multiple clients and ensure its approval, MA transfer, MA withdrawal, RMS transfer, Sunset clause exemption and renewals of marketingauthorizations. Archival & Maintenance: Responsible for archiving and maintaining the files in theappropriate Document Management Systems (DMS), publish & maintain life cycle of eCTDsubmissions, Ready! update and Article 57 database update. Submission Portals: Acquaintance with CESP, Portugal (SMUH-AIM) portal. Dossier Compliance Checks: Performed dossier compliance check activity for 53 products. Co-ordination: Co-ordinate with various departments for collection of various technical documents asrequired for registration. Co-ordinate with stakeholders and various customers for new registration, maintenanceof registration status for registered products and fees related activities. Check BMR and BPR as per regulatory requirements. Review change control and perform impact assessment on regulatory submissions

Education

• Govindrao Nikam College of Pharmacy

  Bachelor of Pharmacy (B. Pharm.), Pharmacy

  2005 — 2009

• Institute of Pharmaceutical Management, Mumbai

  Post-Graduate Diploma in Drug Regulatory Affairs (API & Formulation)

Skills

• Hplc
• Regulatory Affairs
• Validation
• Clinical Trials
• Quality Assurance
• Formulation
• Quality System
• Pharmacists
• Technology Transfer
• Manufacturing
• Pharmaceutical Industry
• Glp
• Regulatory Submissions
• Pharmaceutics
• Biotechnology
• Gmp
• Api Manufacturing