cmc - Bengaluru, Karnataka

Manage submissionsPlan submission workload by reviewing/monitoring RIM for planned documents for registration submissions. · ...

The CMC-3 is responsible for contributing to the development of CMC regulatory strategies and executing tasks independently according to global regulations. The role involves leading the preparation and submission of CMC dossiers for life-cycle changes and managing a team of cont ...

+Responsible for developing regulatory CMC strategy for assigned projects. · + · + · Acts as CMC regulatory lead or deputy for complex projects/products. · Manages technical documents for preparation, review and submission to regulatory agencies. · ...

The position is responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages. · ...

This position is based in Bengaluru and will require some on-site work. Responsible for developing regulatory CMC strategy for assigned projects.Identifies and collects CMC data required for regulatory submission packages. · Plans and prepares CMC regulatory packages, assesses ch ...

+Job summary · A Regulatory Affairs Specialist is responsible for developing regulatory CMC strategies and managing technical documents for submission to regulatory agencies. · +Responsibilities · - Acts as CMC regulatory lead or deputy · - Manages technical documents · - Prepare ...

This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. · Astella's Global Capability Centers are strategically located sites that give Astellas the ...

Astellas Pharma Inc. is seeking a Regulatory Affairs Lead– CMC Biologics to develop innovative therapies for patients. · ...

The Company Syngene International Ltd serves the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors with a combination of facilities. · ...

This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. · The GCCs will enhance our operational efficiency, resilience and innovation potential, · en ...

Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. · ...

Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics. · - Job Description · This role is part of Alcon's Quality & Regulatory Affairs function. · ...

+As Regulatory Manager Regional Projects CMC you will have managerial responsibility for a direct reports as well as accountability and lead for the completion of assigned projects in the CMC Rx and Vx regulatory area. · +Managing people aspects of a team of direct reports to cre ...

Support and manage registration maintenance activities for approved products. · Assist in developing and implementing global CMC regulatory strategies for biologics, pharmaceuticals, and devices. · ...

Job summary ...

Lead regulatory affairs specialist for biologics and complex projects. Responsible for global registration packages and ensuring compliance with EMA/FDA/ICH regulations. · ...

This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. · ...

+ Develops and implements global chemistry manufacturing control strategies throughout biologics pharmaceuticals devices lifecycle. · + Prepares directs development CMC submissions market registrations progress reports supplements amendments periodic experience reports. · + Repre ...

Lead Regulatory Affairs for CMC small molecules with 12+ years industry experience in pharmaceutical companies, CRO or academic with at least 6 years experience directly in Regulatory Affairs or in CMC regulatory role. · Last requirement is to have ability to write and speak Engl ...

The Regulatory Affairs Specialist will support CMC regulatory activities for Astellas' products in accordance with global regulations and guidelines. The position requires a strong understanding of scientific information, ability to critically review detailed data, and proficienc ...