Regulatory Affairs Specialist
2 weeks ago
About UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter Expert (SME) with 5–8 years of experience in the pharmaceutical or life sciences industry. The ideal candidate will provide strategic and operational expertise in global and regional regulatory requirements and submissions. This role involves collaborating with cross-functional teams across clinical, CMC, medical, and quality functions to ensure compliance with health authority regulations.Key Responsibilities:Provide subject matter expertise in global and regional regulatory requirements and submissions.Review and interpret regulatory guidelines to support product development and lifecycle management.Partner with cross-functional teams (clinical, CMC, medical, and quality) to ensure compliance with applicable regulations.Prepare, review, and maintain regulatory documents including INDs, NDAs, MAAs, CTDs, and other agency submissions.Support responses to health authority queries and regulatory audits.Track and implement changes in regulatory frameworks impacting ongoing and future submissions. Required Skills:Strong understanding of global regulatory processes (USFDA, EMA, CDSCO, etc.).Hands-on experience with eCTD submissions and regulatory strategy development.Excellent analytical, documentation, and communication skills.
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regulatory affairs
1 week ago
bengaluru, India Randstad Full timeWhat do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Delhi, NCR, Vellore, India Airvin Skills Full time ₹ 2,00,000 - ₹ 8,00,000 per yearEWe are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and...
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Regulatory Affairs
4 days ago
Bengaluru, Karnataka, India UST Full timeRole DescriptionJob Title: Regulatory Affairs Associate – Authoring.Role detailed classificationRegulatory Affairs AuthoringJob Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, India Seven Consultancy Full timeJob Description - Develop and implement regulatory strategies to ensure compliance with applicable laws and industry regulations. - Prepare, review, and submit regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. - Collaborate with cross-functional teams, including R&D, Quality Assurance,...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Specialist
1 week ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Specialist
1 week ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI:UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview:We are seeking a Regulatory Affairs Subject Matter Expert...
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Regulatory Affairs Specialist
1 week ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
