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Teva Sr Mgr Regulatory Affairs India, Maharashtra, Navi Mumbai 515687515
25.06.2024
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The opportunity
- 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.
How you’ll spend your day
- 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.
Your experience and qualifications
- 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.
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