8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

Job Description: As a Regulatory Affairs - CMC Specialist at Novartis, you will be responsible for activities related to chemistry, manufacturing, and control (CMC) for regulatory submissions to Health Authorities. Your role will involve formulating and leading global CMC regulatory strategy, authoring high-quality CMC documentation, and interacting with Health Authorities to support product launches. Key Responsibilities: - Lead global CMC regulatory strategy, focusing on innovation while ensuring regulatory compliance - Manage all global CMC submission activities for assigned projects/products - Identify required documentation for global submissions and negotiate delivery of approved techn...

Posted 4 days ago

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Regulatory Affairs CMC Manager Novartis India

8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs-CMC Specialist at Novartis, your role will involve handling regulatory activities related to chemistry, manufacturing, and control (CMC). You will be responsible for preparing and publishing REG CMC documentation for submissions to Health Authorities. Additionally, you will interact with Health Authorities on REG CMC questions to support new product launches and post-market activities. Key Responsibilities: - Formulate and lead global CMC regulatory strategy, focusing on innovation while ensuring regulatory compliance. - Lead and oversee all global CMC submission activities for assigned projects/products. - Identify required documentation for global submissions, addre...

Posted 5 days ago

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