6 Regulatory Associate Jobs

Regulatory Associate Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to h...

We are Reckitt Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development, were full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, o...

Title: Regulatory Associate Date: 8 Jul 2025 Location: Bangalore, KA, IN Job Description We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.comLooking to jump-start your careerWe understand how important the first few years of your career are, which...

Compilation , review of dossier for US , EU , AU, Canada & IL market for both solid oral and non-oral dosage form Review of query response prepared and compiled by regulatory associates Manage all the activities pertaining to dossier submission for aforesaid markets . Meet the dossier submission and query response timeline as per given target Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities Lifecycle management for US , EU , Canada & IL market Single point contacts for all the regulatory submission activities fo...

Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like - US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, prepar...

The NFR Audit and Regulatory Associate is a member of the NFR Audit and Regulatory team and supports Audit and Regulatory related activities for the programs in the NFR organizations, including Cyber and Technology Risk, Third Party Risk, Data Risk, New and Changing Business Activities, Risk Treatment and Reporting, Risk Quantification, Operational Risk, Operational Resilience, Fraud, Privacy, and Insider Threat. The primary responsibilities include data collection and document management, tracking engagement timelines, updating the program documentation library and SharePoint, updating status reports, document review and packaging, tracking deliverable status and providing status updates, a...