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: Preparation and submission of variations for UK manufacturing licenses Dealing with PIL and SmPC uploads and maintenance on eMC website Review and approval of UK packaging materials artworks and maintenance proper archive Tracking of Sunset Clause activities Assist in obtaining Certificates of a Pharmaceutical Product and notarization/legalization of these where required Provision of advice and/or information to teams such as the Quality, Marketing and Medical Information teams.
Requirements and Qualifications :
Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three year experience in EU Regulatory Affairs incl.
New Applications Fluent in English is mandatory as it is used as the main communication language Experience with eCTD and LORENZ docuBridge publishing is required Experience with MHRA is recommended Experience in project management is beneficial Digital Savvy, with good knowledge of MS Office and RA related software like AMS, RIMS, XEVMPD/ IDMP Ability to work in a team, analytical thinking, good eye for detail, flexibility, assertiveness, communication skills Hours per week : 40