Pharmaceutical Compliance Manager
2 days ago
Estimated Salary: $90,000 - $125,000 per annum
About Dr. Reddy's LaboratoriesWe are a multinational pharmaceutical company committed to providing affordable and innovative medicines. Our team of 24,000 plus employees works together to achieve our mission.
Key ResponsibilitiesThe ideal candidate will prepare, submit, and coordinate UK MAA procedures, national variations, and renewal procedures. They will also review and assess registration dossiers, support product launch activities, and maintain internal and external contacts.
Additionally, the candidate will provide advice and information to teams such as Quality, Marketing, and Medical Information. They will also deal with PIL and SmPC uploads, review packaging materials artworks, and track sunset clause activities.
Qualifications and Requirements- Study/Degree in Pharmaceutical Sciences or Life Sciences with at least three years of experience in EU Regulatory Affairs incl. New Applications
- Fluent in English, used as the main communication language
- Experience with eCTD and LORENZ docuBridge publishing required
- Project management skills beneficial
- Digital Savvy, with good knowledge of MS Office and RA related software like AMS, RIMS, XEVMPD/IDMP
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