Role & responsibilities

- Preparation and submission of new Marketing Authorization applications to the regulatory authorities.
- Compilation and review of Module 1 to Module 5 and other supporting documents required for managing the initial submission. Followed by, electronic common technical documents (eCTD) creation for submissions to ensure timely delivery of high quality regulatory submissions according to agreed business priorities and submit it appropriate mode of submission.
- Address agency queries raised during initial application by coordinating with cross functional teams to ensure timely response.
- Communicating with cross-functional team (R&D;, manufacturing site, QA, QC & QPs (Quality and Pharmacovigilance)



to gather all the required information to complies the dossier.
- Communicate with internal clinical team for BE study related documents for module 2 & 5.
- Support line manager for answering queries requested by different customer as and when it is required
- Coordinating with all third-Party Medreich clients and providing regulatory support for current MA application as per the technical agreement.
- Acting as a process owner for regulatory processes (SOP & working procedures) and update as per schedule or as and when it is required.

Preferred candidate profile

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Medreich
📍 Bengaluru