4.0 - 8.0 years

0 Lacs

delhi

On-site

Role Overview: As a Regulatory Global Labeling Operations Specialist, you will play a crucial role in authoring and updating labeling documents, ensuring compliance with Health Authority regulations, and maintaining submission quality. Key Responsibilities: - Oversee EU labels, including EU linguistic quality control (QC) coordination and support. - Coordinate labeling workflow activities and provide support for labeling change controls. - Manage artwork, including designing, reviewing, and updating packaging components. - Responsible for generating and maintaining the Structured Product Labeling (SPL) for all products. - Collaborate with regulatory and product teams to ensure accurate produ...

Posted 1 month ago

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Medical Safety Expert Novartis India

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

Posted 3 months ago

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