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.
Post : Sr Mgr Regulatory Affairs
Job Description
• Act as Project manager (PM) overseeing the support for new registrations using Teva’s proprietary products and achieving Marketing Authorisation (MA) for the Medis business.
• Focus on specific territories such as LATAM, Canada, China etc.
• Take responsibility for planning, preparing, submitting and supporting Marketing Authorisation Applications (MAAs) to Medis clients.
• Evaluate dossier suitability for specific territories.
• Regulatory strategize, prepare and submit MAAs to Medis clients.
• Engage actively and provide extensive support to Medis clients to facilitate MA approvals.
• Coordinate and contribute to responses to deficiency from health authorities and act as primary liaison between R&D, Site RA, Clinical team, Medis clients and other relevant functions.
• Monitor timelines and coordinate the flow of information internally and externally throughout the registrations process until MA approval is obtained.
• Offer regulatory guidance and support to Medis.
• Maintain databases and other document management systems/lists.
• Contribute to specialized projects as directed by Medis RA managers.
• Organize dossier audits and due diligence for clients.
• Provide regular status updates to management.
Candidate Profile
• B.Pharmacy/M.pharmacy/Msc in chemistry.
• 12 to 18 years of experience in Regulatory Affairs
• Expertise in global regulatory strategies.
• Strong skills and in-depth understanding of regulatory environments across various regions including LATAM, Canada, China, etc.
Additional Information
Experience : 12 to 18 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th June 2024
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