Senior regulatory specialist
1 month ago
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements Provide regulatory direction on global regulatory requirements to support product development Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle Support development and execution of clinical/non-clinical strategies Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans with minimal supervision, participate in development of risk management and contingency planning Ensure and lead regulatory compliance for biosimilar products Participation in regulatory meetings with Health Authorities Regulatory Intelligence: Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products Review and assess impact of regulatory decisions for competitive products Generate and communicate biosimilar intelligence
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Regulatory Specialist
3 months ago
bangalore, India Tag Full timeREGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Regulatory Specialist
3 months ago
Bangalore Urban, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story. We...
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Regulatory Specialist
3 months ago
Bangalore Urban, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Global Regulatory Compliance Specialist
2 weeks ago
bangalore, India Gumazing Full timeGumazing , a health-focused brand under Eternal Mark, is seeking an experienced Global Regulatory Compliance Specialist to ensure our supplements and nutraceuticals meet international regulatory standards. This role will act as a liaison between our factories and distributors, ensuring compliance and smooth communication across global markets.Job...
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Global Regulatory Compliance Specialist
2 weeks ago
bangalore, India Gumazing Full timeGumazing , a health-focused brand under Eternal Mark, is seeking an experiencedGlobal Regulatory Compliance Specialistto ensure oursupplements and nutraceuticalsmeet international regulatory standards. This role will act as a liaison between our factories and distributors, ensuring compliance and smooth communication across global markets.Job Summary:The...
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Senior Regulatory Specialist
1 month ago
bangalore, India Biocon Biologics Full timeAccountable for development and execution of CMC regulatory strategies, marketing applicationsand Life Cycle Management for biosimilar products.Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to...
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Senior Regulatory Specialist
2 months ago
bangalore, India Biocon Biologics Full timeAccountable for development and execution of CMC regulatory strategies, marketing applicationsand Life Cycle Management for biosimilar products.Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to...
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Tag | Regulatory Specialist | bangalore
2 days ago
bangalore, India Tag Full timeREGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Tag | Regulatory Specialist | bangalore
2 days ago
bangalore, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Tag | Regulatory Specialist | bangalore
2 days ago
bangalore, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story. We...
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bangalore, India Gumazing Full timeGumazing, a health-focused brand under Eternal Mark, is seeking an experienced Global Regulatory Compliance Specialist to ensure our supplements and nutraceuticals meet international regulatory standards. This role will act as a liaison between our factories and distributors, ensuring compliance and smooth communication across global markets.Job Summary:The...
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bangalore, India Gumazing Full timeGumazing , a health-focused brand under Eternal Mark, is seeking an experienced Global Regulatory Compliance Specialist to ensure our supplements and nutraceuticals meet international regulatory standards. This role will act as a liaison between our factories and distributors, ensuring compliance and smooth communication across global markets. Job Summary:...
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Senior Advisor
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the private office | Senior Advisor
2 weeks ago
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the private office | Senior Advisor
2 weeks ago
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