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Regulatory Affairs Manager

1 month ago

Cambourne, United Kingdom Dr. Reddy'S Laboratories Full time

Job Description Company Overview: Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's") is a leading multinational pharmaceutical company based across global locations.
Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait .
Location: Dr. Reddy's (UK) Ltd, Cambridge (UK) Main tasks: Preparation (esp.
Module 1 and the national texts), submission, coordination and monitoring of UK (national, IRP) MAA procedures Preparation (Module 1, 2 and 3), submission and coordination of UK national variations and renewal procedures and preparation of response documents to deficiency letters Maintenance and communication with internal and external contacts and interfaces, e.g.
regulatory authorities, European affiliates, Headquarter and partners/customers (e.g.
NHS, IL partners) Review, including advice for and assessment of registration dossiers (esp.
Module 1 and 3) prior to each submission step during the marketing authorization applications (MAA) filing process for in-house developments and those for in-licensed products in the UK Support of product launch activities Other regulatory related activities including but not limited to: