Ra Cmc Associate Manager I
4 days ago
Summary -Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities In addition interact with HA s on REG CMC questions to support new product or post marketed launches Major accountabilities Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle applying agreed CMC global regulatory strategies current regulatory trends and guidelines Ensure technical congruency and regulatory compliance meeting agreed upon timelines and e-publishing requirements Identify the required documentation and any content quality and or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines As needed coordinate collect store source documentation needed for direct submission to Health Authorities Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy identifying the critical issues and lessons learned Perform activities in support of the overall department such as data entry into the Regulatory Information Management System other CMC database entry or maintenance and operational activities as needed Reporting of technical complaints adverse events special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples where applicable Minimum Requirements Project Management Operations Management and Execution Collaborating across boundaries Why Novartis Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve this With our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us Learn more here https www novartis com about strategy people-and-culture You ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewards Commitment to Diversity and Inclusion Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to diversityandincl india novartis com and let us know the nature of your request and your contact information Please include the job requisition number in your message Join our Novartis Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here https talentnetwork novartis com network Skills Desired Documentation Management Lifesciences Operational Excellence Regulatory Compliance
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RA CMC Associate Manager I
1 week ago
Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Associate Manager-II
6 days ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Manager
6 days ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Manager
1 week ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Associate Manager I
1 week ago
Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per yearSummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.About the RoleMajor...
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RA CMC Senior Manager
7 days ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearBandLevel 4Job Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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Ra Cmc Manager
2 days ago
Hyderabad, Telangana, India Novartis Full timeSummary Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities In addition interact with HA s on REG CMC questions to support new product or post marketed launches Key responsibilities Formulate and lead...
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Senior Manager RA CMC
1 week ago
Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearSummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC) . Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.About the RoleMajor...
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Regulatory Affairs Manager
4 days ago
Hyderabad, India Amgen Full timeJob 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 commercial products. The RA CMC Manager is responsible for communicating the...
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RA CMC Manager
2 hours ago
hyderabad, India Novartis Full timeJob Description SummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
