Regulatory Affairs

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...

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...

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 Job OpportunityDesired Experience : 3- 9 yearsJob Location : Genome Valley, Shameerpet, HyderabadPreferred Industry : Vaccines / BiotechDesignation: Senior Executive/ ExecutiveQualification: M. Pharmacy/ M. Sc/ B. PharmacyJob Responsibilities:Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World...

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...

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: Regulatory Affairs ManagerAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia.Key Responsibilities:Conduct thorough regulatory reviews of dossier sections (Quality) to ensure...