Regulatory Coordinator

394724BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...

Summary The Senior Regulatory Coordinator Sr RC works under close supervision to support for development including line extension and maintenance projects through development registration and approval including post approval commitments To maximize operational effectiveness Collaborate with RA GDD Development Units RA GDD CMC Regional...

**About the Role**: Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations - Contribute to Module #1...

**Summary**: Supports the provision of timely, high-quality regulatory translations essential for product registration, maintenance, and launches worldwide. **About the Role**: Key Responsibilities - Performs general coordination and administrative tasks to support the “Regulatory Translation Solutions” group functioning. - Grants access to relevant CO...

Your responsibilities include, but are not limited to:• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations• Contribute to Module #1 documents including FDA...

SummaryContributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.About the RoleKey ResponsibilitiesEnsure...

The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used to prepare...

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...

Career Category RegulatoryThe Regulatory Data Systems Senior Associate will be responsible for interpreting and executing business requirements based on a combination of industry best practice and Amgen regulatory processes This role involves optimizing complex data systems supporting the health authority submission process while ensuring compliance...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory...