Nedumathi Thiyagarajan
Regulatory Affairs CMC - MSD Pharmaceuticals Pvt Ltd
- Role
- Senior Scientist - Regulatory Affairs Cmc at MSD
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Nedumathi Thiyagarajan
I’m Nedumathi Thiyagarajan (he/him), completed a post-graduation in Department of…
Experience
Senior Scientist - Regulatory Affairs Cmc
Apr 2017 — Present · Mumbai, IN
As an individual performer, responsible to develop CMC regional strategies for pre-submission and post approval changes. Preparation & review of CMC documentation and new product registrations for small molecule/ Vaccine products, serving as a link between with local Affiliate Drug Regulatory Affairs (DRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities. Handling various change control for APAC region across the product modalities. Responsible for attending the drug product meeting forum regular basis. Ensures awareness of regional regulatory policy and maintain the regulatory intelligence repository for regional markets. Collaboration with product lead, site CMC and local market managers in order to file a post approval submission successfully. Collaboration with Head Quarter (HQ), Local market managers and other stakeholders for filing pre submission to APAC region. Archiving the projects details in the tracker for traceability and visibility. Highlight the supply issues to senior management (LT) right time to resolve those issues to continue supply in the market. Attending training sessions to build up the knowledge. Responding various Health Agencies deficiencies in stipulated timeline. Responding various customer/stakeholder queries in stipulated timeline. Liaison with various stakeholders for obtaining the technical documents for compilation.
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