Regulatory Affairs CMC Associate

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...

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

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 Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...

Regulatory Affairs ExpertKey Responsibilities:Develop and execute CMC regulatory strategies for assigned products to ensure compliance with global regulations and guidelines.Collaborate with cross-functional teams to deliver regulatory milestones for assigned products across the product lifecycle.Lead the development, review, and approval of CMC submission...

Senior Manager - Regulatory Affairs CMCOur company is seeking an experienced Senior Manager to lead our Regulatory Affairs CMC team. In this role, you will be responsible for formulating and implementing global CMC regulatory strategies, maximizing business benefit while ensuring regulatory compliance.The ideal candidate will have a strong background in...

Job Title:Regulatory Affairs Specialist - CMC StrategyJob Summary:We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.Key Responsibilities:Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.Lead the development,...

Key Responsibilities: Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...

Regulatory Affairs Associate Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate Manager to lead our team in Hyderabad, India. The successful candidate will be responsible for regulatory activities related to chemistry, manufacturing, and control (CMC).Main Responsibilities:Author high-quality global CMC documentation for...