CMC Regulatory Affairs Specialist

We are seeking a highly skilled Manager to join our team in the Global CMC & Device Regulatory Affairs department. The ideal candidate will be responsible for developing and maintaining consistency across practices and procedures related to CMC processes.Key Responsibilities:Support new hire onboarding programFacilitate communication across Global CMC &...

Job DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...

Regulatory Affairs Expertise for CMC SubmissionsIn this role, you will lead and manage key activities related to CMC regulatory submissions for USFDA purposes. This includes preparing, reviewing, and filing ANDA documents. You will also oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.You will work closely with...

Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...

Regulatory Affairs Manager Job SummaryThis is a high-profile position responsible for leading the submission of annual reports, facility registrations, and product renewals. The successful candidate will also oversee staff members and act as a primary point of contact for specific submission execution or annual reporting tasks.Key Responsibilities:Lead the...

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...

Regulatory Activities ManagerThis role is responsible for overseeing regulatory activities related to chemistry, manufacturing, and control (CMC) of products. Key tasks include preparing and publishing CMC documentation for submissions to Health Authorities, as well as interacting with HA's on CMC questions to support new product or post-marketed launches.

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...

Regulatory CMC ProfessionalWe are seeking a highly skilled Regulatory CMC Professional to join our team.Key Responsibilities:Prepare and publish REG CMC documentation for submissions to Health AuthoritiesInteract with Health Authorities on REG CMC questions to support new product or post-marketed launchesThe ideal candidate will have strong knowledge of...

Regulatory Expert for Chemistry, Manufacturing and ControlWe are seeking a skilled professional to lead global CMC submission activities.About the Role:This challenging position requires a strong understanding of regulatory requirements and technical expertise in chemistry, manufacturing, and control.Main Responsibilities:Develop strategic plans for global...