Regulatory Affairs Manager
2 days ago
- The 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 strategy, risks and issues to Regulatory and Operations senior management
- The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities
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Regulatory Affairs
2 weeks ago
Hyderabad, Telangana, India Clininfotech Full time ₹ 4,00,000 - ₹ 6,00,000 per yearWe are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...
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Regulatory Affairs Manager
2 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
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Regulatory Affairs Manager
4 days ago
Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearRegulatory Affairs Manager (CMC) Career CategoryInformation Systems Job Description The 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...
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Regulatory Affairs Manager
1 week ago
Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per yearRole DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...
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Regulatory Affairs Specialist
1 week ago
Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full timeCompany DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...
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Regulatory Affairs Manager
6 days ago
Hyderabad, Telangana, India Shri Kartikeya Pharma Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJob Summary:The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).Key Responsibilities:Regulatory Strategy & Compliance.Develop and implement regulatory strategies...
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Regulatory Affairs Manager
2 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRegulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRegulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and...
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Regulatory Affairs Intelligence Manager
2 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per yearThe Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process.Key Responsibilities:Intelligence Gathering &...
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Regulatory Affairs Assistant
2 weeks ago
Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 5,00,000 - ₹ 12,00,000 per yearCompany OverviewGamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at Job OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in...