Regulatory Affairs Manager

Job Summary:","Regulatory Affairs Specialist: Artwork Management and Compliance"],

We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

Role DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...

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 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...

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,...

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

Regulatory Affairs AssociateExperience: 3-6 yearsEducation: Science GraduateLocation: HyderabadSkills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

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...

About the roleWe are seeking a seasoned Regulatory Affairs professional to manage end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions.Manage cross-functional teams to collect required data and documentation for timely regulatory submissions.Compile CMC documentation in compliance with FDA...