2.0 - 4.0 years

4 - 6 Lacs

Bengaluru

Work from Office

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 create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth.We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have Job Summary: The Scientific and Medical content teams work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy areas. In light of this, the role holder in Content Solutions would get an opportunity to learn and partner with healthcare clients on various projects.The Job entails the following but not limited to: Develop, review and edit scientific and medical content meeting International Quality Standards and client organization guidelines for any of the capability belowo Regulatory, Safety, Medical Affairso Medico-marketing, training and Continuous Medical Education (CME)o Commercial Campaigns, digital marketing channelso Content data set preparation, annotation and curationDevelop and prepare content based on target audience (physicians, patients etc.) and mode of deployment (print, web, multi-channels) within short span of time for multiple deliverables Deliver and be able to review content that is rated high on depth, comprehensiveness, quality and timelines within a short span of time Interact with team members to blend the content with creative, technology for projects based on the client needs Interact and defend content based on scientific evidence and facts Demonstrate passion to learn and write for different therapy areas and markets with strong written and verbal communication / presentation skills Be up-to-date with the latest technical /scientific / regulatory developments and applying the learnings on various projects Ability to manage a team within short period of time Good to have EQUAL OPPORTUNITY

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Sr Executive sun pharma industries

4.0 - 8.0 years

6 - 10 Lacs

Vadodara

Work from Office

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 for IL and Palestine markets

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Manager - 1 sun pharma industries

12.0 - 18.0 years

18 - 19 Lacs

Vadodara

Work from Office

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, preparation and submission of post approval supplements to US FDA Reviewing of the plant change control and established the variation strategy for submission Review of query response prepared and compiled by regulatory associates 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

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