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Teva Pharmaceuticals
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Regulatory Affairs Associate I

Regulatory Affairs Associate I

Teva Pharmaceuticals

1 - 5 years

0 Lacs

navi mumbai maharashtra

Posted:4 days ago| Platform: Shine logo

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Skills Required

regulatory affairs project management communication skills computer skills lifecycle management variations team player

Work Mode

On-site

Job Type

Full Time

Job Description

The Regulatory Affairs Associate is a project manager responsible for the RA lifecycle management on Medis dossiers for Teva's 3rd party client business (Medis), ensuring that information flow and provision of supportive documents reach the clients. The PM is responsible for liaising with Teva's 3rd party client business (Medis) supply chain, Teva site RA, and other relevant functions. In this role, you will be responsible for lifecycle management on specific products for Europe and the international market. You will ensure that regulatory modules under your responsibility are up to date and in accordance with agreed procedures. You will inform, prepare, and submit variations either directly to authorities or to Teva's 3rd party client business (Medis). Additionally, you will follow up on variation submissions, timelines, and approvals, compile answers to any deficiency questions from authorities or clients, and ensure timely communication of outcomes of variations. As a Regulatory Affairs Associate, you will provide regular status updates to management, set goals, and follow up with your supervisor. You will engage in professional communications with both internal and external stakeholders and work on other specialized projects as defined by RA managers. To qualify for this role, you should have an M Pharm/ MSc with 2 to 3 years of experience in RA or a B Pharm/BSc with 3 to 5 years of experience in RA. A minimum of one year of relevant experience in the EU is required. Personal characteristics that are essential for this role include good organizational, communication, and presentation skills, as well as proficiency in written and verbal English. Strategic thinking, flexibility to adapt to changes, teamwork, good computer skills, and a proactive approach to work are also important qualities. This position reports to the Manager of Regulatory Affairs. Teva is committed to providing equal employment opportunities.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Regulatory Affairs Associate I