Regulatory Affairs Manager
21 hours ago
We are seeking an experienced Regulatory Affairs Manager to join our team at Intas Pharmaceuticals. This role will be responsible for preparing and submitting applications and dossiers for registration of recombinant products, CGT products in India, and PCT applications.
The successful candidate will have a strong background in pharmaceutical regulations, excellent communication skills, and the ability to work independently. They will also be responsible for reviewing and submitting applications for MAA, PAC, CT, Form 11, Form CT-10, Form CT-16, and Dual Use NOC to obtain relevant DCGI approvals.
In addition, the Regulatory Affairs Manager will be responsible for updating and preparing the dossier and documents, as well as responding to queries raised by regulatory agencies. They will also impart training to subordinates on document preparation and guidance.
This is a challenging opportunity for someone who enjoys working in a fast-paced environment and has a keen eye for detail. If you are a motivated and organized individual with excellent communication skills, we encourage you to apply.
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Regulatory Affairs Manager
2 weeks ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a...
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Regulatory Affairs Manager
2 weeks ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...
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Regulatory Affairs Manager
2 weeks ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal PharmaAs a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...
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Regulatory Affairs Specialist
3 weeks ago
India Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...
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Regulatory affairs manager
2 days ago
India Zeon Lifesciences Ltd Full timeThe Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU),...
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Regulatory Affairs Specialist
21 hours ago
India BioTalent Search Private Limited Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bengaluru. As a key member of our organization, you will play a vital role in ensuring compliance with regulatory requirements and driving the success of our medical device testing business.About Us:BioTalent Search Private Limited is a...
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Regulatory Affairs Specialist
21 hours ago
India Biocon Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon in US/Canada Market. This role is an exciting opportunity for individuals with experience in formulation regulatory affairs.Key ResponsibilitiesPrepare, review and submit ANDA/ANDS in the US Market, including modules.Contribute to life cycle management for...
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Regulatory Affairs Expert with Global Compliance
2 weeks ago
India Apsida Life Science Full timeApsida Life Science is seeking a Regulatory Affairs Specialist for a long-term project in the Asia-Pacific region. The ideal candidate will have expertise in regulatory requirements for Vietnam, Philippines, Thailand, Malaysia, Singapore, and other ROW countries.The role involves providing strategic guidance on regulatory compliance, collaborating with...
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Director Quality Regulatory Affairs
3 weeks ago
India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...
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Director Quality Regulatory Affairs
3 weeks ago
India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...
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India B. Braun Medical Inc. Full time**Job Description**: You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping...
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india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...
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india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...
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india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...
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Manager Clinical Affairs
1 month ago
india Medical Learning Hub Full timeClinical Affairs ManagerJoin the Future of HealthcareTC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions...
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Manager Clinical Affairs
1 month ago
India Medical Learning Hub Full timeClinical Affairs Manager Join the Future of Healthcare TC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs...
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Senior Manager Regulatory Affairs
1 month ago
india Rubicon Research Limited Full timeAbout Rubicon ResearchRubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.Our product portfolio comprises over 250 SKUs across more than 70 product...
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india Zeon Lifesciences Ltd Full timeThe Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food...
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india Zeon Lifesciences Ltd Full timeThe Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food...
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india Zeon Lifesciences Ltd Full timeThe Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food...