Regulatory Affairs Specialist

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

ONLY EXPERIENCE CANDIDATE CAN APPLYJob description: -We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidatemust have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation, specifically forLATAM & ROW. Responsibilities include dossier preparation, label review, and...

Job Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools...

Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

About the Company Embarking on the frontier of technological progress, Discrete Circuits Pvt. Ltd. takes pride in its commitment to pioneering innovation and delivering state-of-the-art solutions that dynamically cater to our customers' evolving needs. Our journey unfolds through a comprehensive process, beginning with extensive research, leading to...

Job Title:Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)Department:Regulatory & Safety – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – Regulatory & SafetyJob Purpose:To manage and coordinate regulatory documentation and compliance activities for radiology and imaging systems such as...

Responsibilities:* Manage government relationships for solar projects and AAC blocks* Ensure regulatory compliance at PWD and CPWD levels* Coordinate corporate affairs with government agenciesemail: satish: 88O2749743

Position Overview:The RM Store Specialist will be responsible for managing, monitoring, and controlling raw material inventory in compliance with organizational and regulatory standards. The role ensures the timely availability of raw materials, accurate record keeping, and adherence to safety and quality standards.Key Responsibilities:Manage day-to-day...

Company OverviewRayzon Green is a pivotal subsidiary of Rayzon Solar, specializing in managing engineering, procurement, and construction projects. With a focus on optimizing project outcomes while ensuring cost-effectiveness and resource efficiency, the company strives to deliver superior results. Based in Surat, Rayzon Green operates within the solar...