Regulatory Affairs Manager

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 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...

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

Job Description- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met- Provide regulatory support for research and development activities and ensure compliance with Indian and...

Senior Regulatory Specialist Job DescriptionThis role involves leading the preparation and submission of FDA 510(k) premarket notifications for medical devices. You will be responsible for preparing and reviewing regulatory documentation to ensure compliance with FDA regulations and standards.Key Responsibilities:Develop strategic plans for regulatory...

Job Title: Senior Regulatory Affairs SpecialistOverviewKamet Consulting Group is a leading management consulting firm serving the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our team.Key ResponsibilitiesMonitor and analyze regulatory changes, trends, and developments in the pharmaceutical and...

This role is for one of the Weekday's clientsSalary range: Rs Rs ie INR LPA)Min Experience: 3 yearsLocation: HyderabadJobType: full-timeWe are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, 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 &...

This role supports the Regulatory Translation Hub by managing access to repository folders, maintaining software licenses and updating team lists.Key ResponsibilitiesCoordinates general administrative tasks for the Regulatory Translation Hub.Manages access to relevant repositories, maintains records and ensures software renewal.Organizes documentation,...

Job Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose ...