Regulatory Affairs CMC

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 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...

Sr. Associate Regulatory Affairs Career CategoryRegulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of...

Job 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...

GreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...

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...

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...

The RA CMC Senior 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 Senior Manager is responsible for communicating the...

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 compliance with applicable...