- Managing the Product life cycle (post-approval variations), submission of Renewals and Sunset clause exemption application as per the current Regulatory Authority requirement.
- Compilation and review of Module 1 (administrative documents), module 2, Module 3 (Chemistry Manufacturing and Controls (CMC)) and other supporting documents required for managing the product life cycle. 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.
- Managing process licenses (MIA & WDA) and update as and when it is required via an appropriate variation procedure to reflect the current information all the time.
- Address agency queries raised during variation application by coordinating with cross functional teams to ensure timely response.
- Ensure all the product information (SmPC, PIL & Labeling) is updated when necessary and subsequent approved artwork is accurately recorded and communicated.
- Communicate with health authority to expedite the critical submission as and when it is required.




- Coordinating with all third-Party Medreich clients located in UK and EU and providing regulatory support as per the technical agreement.
- Providing Regulatory support to team on Product initiation form (PIFs), Change controls, new product initiation (NPI) form for recent launch products and Responsible for batch release activity by ensuring all the checks are in place.
- Organizing and delegating tasks to fellow team members and ensuring adherence to variation application timelines.
- Maintaining Databases for the Regulatory activities of EU/UK Market.
- Ensure timely completion of assigned regulatory impact assessment, deviation and CAPA.
- Acting as a process owner for regulatory processes (SOP & working procedures) and update as per schedule or as and when it is required.
- Interaction with Manufacturing sites, Artwork team, Quality Control, Quality Assurance, Pharmacovigilance and QPs (Quality and Pharmacovigilance) on Marketing Authorisation related issues.
- Participate in internal self-inspection program and provide support in health authority/customer audit as and when it is required.

📌 Regulatory affairs Specialist (Bengaluru)
🏢 Medreich
📍 Bengaluru