
Cmc regulatory specialist
4 days ago
Job Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a comprehensive global CMC regulatory strategy that balances innovation with compliance. Lead the planning, authoring, reviewing, coordination, and submission of global CMC documents for assigned projects/products. Prepare high-quality CMC documentation for health authority submissions by applying agreed-upon global regulatory strategies, current trends, and guidelines. Ensure the technical congruency and regulatory compliance of submitted documents, meeting agreed timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned for major submissions and escalate as necessary. Initiate and lead interactions with health authorities, setting objectives, preparing briefing books, coordinating rehearsals, and risk mitigation plans. Requirements: Experience working with drug products is essential. Operational management and execution are crucial. Collaboration across teams is vital. Project management skills are necessary. Negotiation, project management, and regulatory compliance are key.
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Global CMC Regulatory Expert
4 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 17,50,000CMC Regulatory Specialist Job SummaryWe are seeking a highly skilled CMC Regulatory Specialist to support our global regulatory strategy.
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CMC Regulatory Specialist
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,00,00,000Regulatory Activities ManagerThis role is responsible for overseeing regulatory activities related to chemistry, manufacturing, and control (CMC) of products. Key tasks include preparing and publishing CMC documentation for submissions to Health Authorities, as well as interacting with HA's on CMC questions to support new product or post-marketed launches.
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CMC Regulatory Specialist
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 17,50,000Job Summary:-Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities:Develop a...
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CMC Regulatory Specialist
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000Regulatory CMC ProfessionalWe are seeking a highly skilled Regulatory CMC Professional to join our team.Key Responsibilities:Prepare and publish REG CMC documentation for submissions to Health AuthoritiesInteract with Health Authorities on REG CMC questions to support new product or post-marketed launchesThe ideal candidate will have strong knowledge of...
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CMC Regulatory Specialist
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,15,000Regulatory Expert for Chemistry, Manufacturing and ControlWe are seeking a skilled professional to lead global CMC submission activities.About the Role:This challenging position requires a strong understanding of regulatory requirements and technical expertise in chemistry, manufacturing, and control.Main Responsibilities:Develop strategic plans for global...
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Regulatory Affairs Specialist
1 day ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...
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CMC Regulatory Strategist
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000About Our CMC Regulatory Role:Seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to lead global CMC submission activities.Develop and implement strategic plans for global CMC regulatory submissions.Lead and manage global CMC submission projects.Author high-quality CMC documentation for health authority submissions.Ensure...
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Global CMC Regulatory Professional
1 week ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Regulatory Specialist Job OverviewThis role involves preparing and publishing regulatory documentation for health authorities. The individual will interact with these authorities on chemistry, manufacturing, and control (CMC) related questions to support the launch of new or existing products.Main Responsibilities:Create a comprehensive global CMC regulatory...
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Cmc regulatory expert
1 week ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
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Cmc Regulatory Expert
2 weeks ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team.This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities.The ideal candidate will have...