Pharmacovigilance

Regulatory Affairs Associate Require at Teva Pharmaceutical | M.Pharm, B.Pharm

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.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.

Post : Regulatory Affairs Associate II (EU Post Approval)

Job Description
• Lifecycle management on specific products for Europe and international markets
• 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
• Provide regulatory guidance and support to  other functions and Teva’s 3rd party client business (Medis)
• Training & mentoring team members
• Participate in writing and update SOP/Work Instructions and process improvements
• Professional communications with both internal and external stakeholders
• Work on other specialised projects as defined by managers of RA

Candidate Profile
M Pharm/ MSc: 5+ years of experience in RA
B Pharm/BSc: 6+ years of experience in RA

Additional Information
Experience : 5+ years
Qualification : B.Pharm/BSc; M.Pharm/MSc
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 28th February, 2021

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