Samruddhi Kulpe

Experience

1. Jr Officer Regulatory Affairs

   Ipca Laboratories Limited

   Jan 2025 — Present

   Facilitating the preparation and compilation of registration dossiers for the EU and UK markets in compliance with European and MHRA regulatory guidelines. • Ensuring timely coordination and support for query responses raised by regulatory authorities and customers. • Assisting with the preparation of post-approval variation applications in line with applicable regulatory requirements. • Liaising with cross-functional teams including Quality Assurance, Quality Control, Production, R&D, Packaging Development, Marketing, and other relevant departments to gather technical inputs and ensure alignment with submission needs. • Supporting the review of technical documents received from various departments to verify accuracy and readiness for inclusion in regulatory applications. • Coordinating discussions with internal stakeholders to finalize required information for submissions and agency queries. • Assisting with maintaining up-to-date databases to track submissions, variations, supplements, grants, and approvals. • Staying updated on changes in regulatory guidelines to ensure compliance with evolving EU/UK requirements.

Education

• Bhavans College

  BSC, chemistry

• Institute of pharmaceutical management

  Post graduate diploma, Advance Regulatory affairs

• Chikitsak Samuhas Sir Sitaram and Lady Shantabai Patkar College of Arts and Science and V R Varde College of Commerce and Economics S V Road

  Masters in RA QA QC & AD