Regulatory Affairs Professional

1 week ago

Mumbai, Maharashtra, India beBeeLabeling Full time ₹ 5,00,000 - ₹ 8,00,000

We are seeking a highly skilled Global Labeling Specialist to join our team.

The Global Labeling Specialist will be responsible for managing global labeling details, including labels, cartons, package inserts, and patient package inserts to ensure compliance, quality, and accuracy. This role involves collaboration with cross-functional teams for regulatory submissions, evaluations, and approvals.

In this position, you will prepare labeling-related documents, such as SmPC, PIL, and other texts for EU submissions. You will also coordinate with stakeholders to ensure timely submission and approval of labeling, and address any related queries.

Additionally, the Global Labeling Specialist will proofread all types of label copy and annotations at various developmental stages to ensure accuracy. This includes creating Structured Product Labeling (SPL) for US Human and Veterinary product submissions, including drug listings, annual establishment registration, and GDUFA self-identification.

You will monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparisons with reference listed drugs (RLDs). The Global Labeling Specialist will also oversee the development and updates of Core Data Sheets (CCDS) for PCC products and manage local labeling updates.

Furthermore, this role involves contributing to the development and review of labeling aspects in promotional materials. You will develop and maintain a central repository for all labeling components.

To be successful in this position, you will need to have a B.Pharm or M.Pharm degree. The ideal candidate will have 4 years of relevant regulatory experience, with a preference for global experience in US, EU, and major Rest of World markets.

Key skills and qualifications include strong interpersonal and organizational skills for effective collaboration, in-depth knowledge of Health Authority labeling regulations and requirements, self-motivation, organization, and adaptability with a high level of accountability.

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