Cmc regulatory expert
24 hours ago
Job 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 experience in formulating and leading global CMC regulatory strategies, authoring high-quality CMC documentation, and ensuring technical congruency and regulatory compliance.Key Responsibilities: Develop and implement global CMC regulatory strategies that balance business needs with regulatory requirements. Lead and manage global CMC submission activities, including planning, authoring, reviewing, coordination, and submission. Author and/or review high-quality CMC documentation for health authority submissions. Ensure technical congruency and regulatory compliance across all regions. Collaborate with cross-functional teams to identify and address quality and compliance issues. Prepare and communicate CMC risk management assessments and contingency plans. Requirements: Pharmaceutical industry experience with a focus on chemistry, manufacturing, and control. Strong knowledge of regulatory requirements and guidelines, particularly those related to CMC. Proven track record of leading global CMC submission activities. Excellent communication and project management skills. Bachelor's degree in a relevant field, such as pharmaceutical science or chemistry. Benefits: We offer a competitive salary and benefits package, including comprehensive health insurance and a 401(k) plan. Ongoing training and development opportunities to help you grow your career. A dynamic and collaborative work environment with a diverse team of professionals. Why Join Our Team? We are a leading company in the pharmaceutical industry, dedicated to delivering innovative medicines and improving patient outcomes. As a member of our team, you will have the opportunity to make a meaningful contribution to our mission and advance your career in a fast-paced and exciting industry.
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CMC Regulatory Expert
4 days 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
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 43,33,814 - ₹ 86,67,628Job 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 Strategist
16 hours 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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CMC Regulatory Expert
15 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Key Responsibilities:The ideal candidate will be responsible for finalizing CMC regulatory strategies for assigned products, including biological products.Develop and execute regulatory strategies by leading the development, review and approval of CMC submission components and documentation.Lead change control evaluation, preparation and submission of CMC...
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CMC Regulatory Specialist
1 day 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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CMC Regulatory Expert
21 hours ago
Hyderabad, Telangana, India beBeeChemistry Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Summary:The Chemistry, Manufacturing and Control (CMC) Manager will be responsible for leading global regulatory activities related to CMC for assigned projects/products.Key Responsibilities: Develop and implement a global CMC regulatory strategy that balances innovation with compliance.Lead global CMC submission activities, including planning,...
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Global CMC Regulatory Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 17,00,000Job Title: Chemistry, Manufacturing and Control Regulatory SpecialistWe are seeking an experienced professional to lead our global Chemistry, Manufacturing and Control (CMC) regulatory strategy. This challenging role requires a strong understanding of regulatory requirements and the ability to develop and implement effective CMC submission activities.Main...
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CMC Regulatory Specialist
2 days 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
2 days 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
2 days 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...
