Regulatory Affairs Executive

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...

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...

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

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 coordinateregulatory documentation and compliance activitiesforradiology and imaging systemssuch asX-Ray,...

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...

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...

Job Purpose:To lead regulatory submissions and compliance activities for cardiovascular medical devices, specifically drug‑eluting stents, balloon catheters, and related vascular devices. Ensure adherence to Indian Medical Device Rules (MDR 2017), ISO 13485, and EU MDR.Key Responsibilities:• Prepare and submit regulatory applications for stents and...

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

Job Title:Quality Control Executive – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)Department:Quality Assurance – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – Quality AssuranceJob Purpose:To ensure product and process compliance in the manufacturing of radiology and imaging systems including X-Ray, C-Arm,...