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Mgr, RA EU Generics Labeling

6 - 10 years

0 Lacs

karnataka

Posted:4 days ago| Platform: Shine logo

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Skills Required

regulatory affairs pharmacovigilance pharmaceutical industry training labeling medical expertise eu procedures readability studies patentrelated issues scientific work authority communication ms office skills

Work Mode

On-site

Job Type

Full Time

Job Description

As an experienced professional in the pharmaceutical industry, you will be responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English product information for European procedures. In this role, you will work with innovative, biosimilar, and generic products, contributing to regulatory compliance and addressing internal and authority-related inquiries. Your day-to-day activities will involve creating and updating compliant English product information for EU procedures, strategic planning for changes affecting multiple product documents, evaluating and approving change requests, and coordinating submissions with EU regulatory units. Additionally, you will collaborate on patent-related issues, contribute to readability studies, and ensure compliance with legal requirements. You will also be involved in monitoring safety updates from EU authority websites, tracking reference product updates and legal changes, assessing the need for updates based on Company Core Safety Information, implementing safety updates in line with SOPs, and participating in Product Safety Group Meetings. Your role will also include scientific work, authority communication, coordination of packaging mockups, addressing authority queries, and assisting with training new team members. To excel in this position, you should have 6 to 7 years of experience in medicinal information and EU labeling in the pharmaceutical industry, ideally in Regulatory Affairs. A completed university degree in natural sciences, such as Pharmacy, Biology, Human Biology, Medicine, or Food Chemistry, preferably with a PhD, is required. Proficiency in spoken and written English, strong MS Office skills, and knowledge of European pharmaceutical law and regulatory affairs are essential for success in this role. If you are looking to be part of a global team dedicated to making good health more affordable and accessible, this opportunity to contribute to the regulatory compliance of life-changing medicines may be the perfect fit for you.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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