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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 supply chain management communication skills stakeholder management strategic thinking teamwork computer skills information flow management lifecycle management variations submission

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Regulatory Affairs Associate at Teva, you will be a project manager responsible for the Regulatory Affairs lifecycle management on Medis dossiers for Teva's 3rd party client business (Medis). Your main task will involve ensuring that information flow and provision of supportive documents reach the clients. You will be liaising with Teva's 3rd party client business (Medis) supply chain, Teva site RA, and other relevant functions. Your role will focus on lifecycle management of specific products for Europe and the international market, ensuring regulatory modules under your responsibility are up to date and in accordance with agreed procedures. Key Responsibilities: - Inform, prepare, and submit variations either directly to authorities or to Teva's 3rd party client business (Medis) - Follow up on variation submissions, timelines, and approvals - Compile answers to any deficiency questions from authorities or clients - Ensure timely communication of outcomes of variations - Provide regular status updates to management and set goals - Engage in professional communications with internal and external stakeholders - Work on other specialized projects as defined by RA managers Qualifications Required: - M Pharm/ MSc with 2 to 3 years of experience in Regulatory Affairs or B Pharm/BSc with 3 to 5 years of experience in Regulatory Affairs - Minimum of one year of relevant experience in the EU - Good organizational, communication, and presentation skills - Proficiency in written and verbal English - Strategic thinking, flexibility to adapt to changes, teamwork, good computer skills, and a proactive approach to work,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Regulatory Affairs Associate I