Cmc regulatory specialist
4 weeks 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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CMC Regulatory Affairs
2 weeks ago
Hyderabad, Telangana, India Freyr Solutions Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPrimary Responsibilities:Responsible for finalizing the CMC regulatory strategies for assigned products (Biological products) and provide support to execute tasks independently in accordance with global regulations and guidance procedures.Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for...
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Regulatory Affairs CMC
7 days ago
Hyderabad, Telangana, India Vipsa Talent Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC
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Regulatory Affairs CMC Associate
4 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...
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Manager, Regulatory Affairs CMC
7 days ago
Hyderabad, Telangana, India MSD Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...
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Manager, Regulatory Affairs CMC
6 days ago
Hyderabad, Telangana, India MSD Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...
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Regulatory Affairs CMC Associate
3 weeks ago
Hyderabad, Telangana, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...
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Regulatory Affairs Manager – Cmc
4 weeks ago
Hyderabad, Telangana, India Vueverse. Full timeKey Responsibilities: Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...
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RA CMC Manager
4 weeks ago
Hyderabad, Telangana, India Sandoz Full timeJob DescriptionMajor accountabilities:- Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.- Identify the required...
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Regulatory Affairs Manager
7 days ago
Hyderabad, Telangana, India Amgen Full time ₹ 15,00,000 - ₹ 25,00,000 per yearThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCareer CategoryInformation SystemsJob DescriptionThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is...
