Regulatory Affairs Lead
2 weeks ago
Regulatory Affairs ExpertThis position is responsible for managing regulatory submissions across multiple products and countries. The ideal candidate will have a strong understanding of global dossier formats, submission pathways, and lifecycle management.Key Responsibilities:Author and compile regulatory dossiers to global health authorities, including the US FDA, EMA, MHRA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules.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.Coordinate responses to health authority queries through cross-functional collaboration and data collation.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.Requirements:8-10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.
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Global Regulatory Affairs Expert
1 week ago
surat, India beBeeRegulatory Full timeJob OverviewThis is a high-level overview of the Regulatory Affairs Specialist position. The Regulatory Affairs Specialist will be responsible for managing global regulatory submissions.Key Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA,...
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Regulatory Affairs Executive
1 week ago
Sachin, Surat, Gujarat, India Globela Pharma Pvt. Ltd. Full time**Job Description: Regulatory Affairs Executive (Fresher to 3 Years Experience)** **Position**: Regulatory Affairs Executive **Department**: Regulatory Affairs **#### **Key Responsibilities**: - **Regulatory Submissions**: - Prepare and submit regulatory documents to health authorities (FDA, EMA, TGA, etc.) for new products, amendments, and...
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Regulatory Affairs Executive
3 days ago
Surat, Gujarat, India Trident Lifeline Full timeONLY 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...
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Regulatory Affairs Executive
6 days ago
Surat, Gujarat, India Discrete Circuits Pvt. Ltd Full timeAbout 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...
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Associate Regulatory Affairs
1 week ago
Surat, India Elevate Life Science Full timeTo prepare/submit/review technical documentation for the international registration of products - To prepare/update/review the Technical Master File for the current product - To prepare/review Technical Change Notifications to the Regulatory Authority - To review Application/ Query related to DCGI (GMP, Manufacturing license), state FDA, local FDA, Central...
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Senior Regulatory Affairs Professional
2 days ago
surat, India beBeeRegulatory Full timeJob OverviewWe are seeking a seasoned professional to fill the role of Senior Regulatory Affairs Associate.The successful candidate will possess in-depth knowledge of regulatory frameworks and procedures, enabling them to effectively manage submissions and applications across various regions.ResponsibilitiesRegulatory Submission Management: Collaborate with...
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Regulatory Affairs Executive
2 weeks ago
Surat, Gujarat, India Trident Lifeline Pvt. Ltd. Full time**Job description: - ** **Key Responsibilities**: - Handle **regulatory documentation** and submissions for **Nutraceutical and Cosmetic** products (domestic & export). - Prepare dossiers, technical files, and product registrations as per **domestic (FSSAI, CDSCO & Ect.)** and **international regulations**. - Ensure products comply with all **legal and...
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Surat, India Seven Consultancy Full timeJOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formats Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintaining familiarity with company product ranges Planning, undertaking and overseeing product trials and...
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Surat, India Seven Consultancy Full timeJOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formats Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) Maintaining familiarity with company product ranges Planning, undertaking and overseeing product trials and...
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Regulatory Affairs Manager
2 weeks ago
Surat, India Zydus MedTech Full timeJob 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...
