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
