Teva is on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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 to 3 years of experience in RA
• B Pharm/BSc: 3 to 5 years of experience in RA
• Minimum one year relevant experience in EU.
• Good organization skills
• Good communication and presentation skills
• Good written and verbal knowledge in English
• Strategic thinking and flexibility to adapt to changes
• Good team player
• Good computer skills
• Proactive way of working and able to work independently
Additional Information
Experience : 2 to 5 years
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th November 2024
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