Regulatory Affairs Specialist –
1 week ago
Key Responsibilities:Regulatory Submissions & Compliance Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others. Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5). Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD. Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals). Coordinate responses to health authority queries through cross-functional collaboration and data collation. Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions. Project Planning & Management Manage regulatory submissions for multiple products across multiple countries simultaneously. Utilize project management tools to track project milestones, timelines, and deliverables. Ensure efficient time and resource allocation to meet submission deadlines. Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements: 8–10 years of core experience inRegulatory Affairs , handling submissions acrossregulated and RoW markets . Strong understanding ofglobal dossier formats, submission pathways, and lifecycle management. Excellent cross-functional communication and coordination skills. Proven ability to manage complex multi-country regulatory portfolios.
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Global Regulatory Affairs
7 days ago
vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
1 week ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
6 days ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
6 days ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
5 days ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
7 days ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
7 days ago
Vapi, India Meril Full timeKey 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...
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Global Regulatory Affairs
7 days ago
Vapi, India Meril Full timeKey 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...
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Regulatory Affairs Specialist
4 weeks ago
Vapi, India Meril Full timeJoin our team as a Regulatory Documentation Specialist focused on IVF buffer media and sterile life science products. The ideal candidate will have strong expertise in regulatory compliance & documentation.Qualifications:🎓 Master’s in Biology / Biotechnology / Life Sciences🧾 3–5 years’ experience in regulatory documentation for sterile or...
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Regulatory Affairs Executive
2 weeks ago
Vapi, Gujarat, India Meril Full time ₹ 12,00,000 - ₹ 24,00,000 per yearJob 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,...
