Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
Post : Regulatory Affairs Associate I
Job Description
• The Regulatory Affairs Associate is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva’s 3rd party client business (Medis), ensuring information flow and provision of supportive documents reaches the clients.
• The PM is responsible for liaison with Teva’s 3rd party client business (Medis) supply chain, Teva site RA and other relevant functions.
• Lifecycle management on specific products for Europe and international market
• Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable.
• 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, in accordance with agreed procedure as applicable.
• Compile answers to any deficiency questions from authorities or clients
• Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable.
• Regular status updates to management
• Goal setting and follow up together with his/her supervisor.
• Professional communications with both internal and external stakeholders
• Work on other specialized projects as defined by managers of RA.
Candidate Profile
• M.Pharm/ MSc: 2 -3 years of experience in RA
• B.Pharm/BSc: 5+ years of experience in RA
Additional Information
Experience : 3+ yrs
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 52304
End Date : 30th November, 2023
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