Regulatory Affairs Professional

Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...

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 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...

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...

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...

Senior Regulatory Specialist RoleWe are seeking a highly skilled and experienced professional to lead our regulatory affairs team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions.This role involves working closely with cross-functional teams to ensure compliance with regulatory...

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,...

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...

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,...

Compliance Manager - Health & MotorThe role of Compliance Manager – Health & Motor involves overseeing the compliance function within an organization. The successful candidate will have a strong background in regulatory affairs, insurance industry practices, and governance.Key ResponsibilitiesFile periodic compliance returns with relevant...