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Senior Regulatory Affairs Associate- Labeling
1 week ago
When our values align, there's no limit to what we can achieve.
Regulatory Affairs Labeling
Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) The ability to research and create comparator labeling documents. Strong understanding and experience creating annual reports. The ability to collaborate with Tech Ops for artwork implementation. Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Electronic document management systems use and / or electronic submission experience. Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.-
Regulatory Affairs Associate II
1 week ago
Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full timeThe opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...
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Regulatory Affairs Executive
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Regulatory Affairs Associate II
2 months ago
Navi Mumbai, India Teva Pharmaceuticals Full timeThe opportunityThe RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of applying...
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Regulatory Affairs Associate II
2 months ago
navi mumbai, India Teva Pharmaceuticals Full timeThe opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...
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Regulatory Affairs Associate II
1 week ago
navi mumbai, India Teva Pharmaceuticals Full timeThe opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...
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Regulatory Affairs Associate II
3 weeks ago
Navi Mumbai, India Teva Pharmaceuticals Full timeThe opportunityThe RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of applying...
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Trainee- Labelling, Regulatory Affairs
3 weeks ago
Mumbai, Maharashtra, India Apotex Research Private Limited Full time**About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...
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Regulatory Affairs Associate II
4 weeks ago
Navi Mumbai, India Teva Pharmaceuticals Full timeWho we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...
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Regulatory Affairs Associate II
2 days ago
Navi Mumbai, India Teva Pharmaceuticals Full timeWho we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...
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Vacancy for Regulatory Affairs at Delhi Ncr
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Director Regulatory Affairs
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mumbai, India Apotex Full timeAbout Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...
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Executive- Labelling, Regulatory Affairs
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Mumbai, India Apotex Full timeAbout Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...
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