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

Dr. Reddy's Laboratories jobs

Regulatory Affairs Manager