Regulatory Affairs Manager – Cmc

Regulatory Affairs CMCExperience: 6-11 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, US market, CMC

Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

Primary Responsibilities:Responsible for finalizing the CMC regulatory strategies for assigned products (Biological products) and provide support to execute tasks independently in accordance with global regulations and guidance procedures.Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for...

Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

Job DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...

Job DescriptionResponsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product...

Regulatory 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...

Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...

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...

Job 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...