Regulatory Global Submission Manager GSK

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Regulatory Global Submission Manager at GSK, you will play a crucial role in providing project management support at the submission level for US, EU, and Rest of the World (ROW) markets. Your responsibilities will include: - Collaborating closely with Regulatory Asset Oversight, GRL, and RMT to drive the execution of agreed plans and ensure timely and compliant delivery of submissions. - Outlining content deliverables, target timelines, submission preparation activities, and interdependencies within the Regulatory Matrix Team (RMT). - Conducting critical path analysis and scenario planning to evaluate strategies for accelerated submission timelines. - Working with publishing and operati...

Posted 4 weeks ago

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Senior Regulatory Manager Biocon Biologics

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, a...

Posted 3 months ago

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