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Regulatory Affairs _ US Market
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Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 25,00,000 - ₹ 35,00,000About the Regulatory Affairs Manager position in a professional services firm.The job entails leading the preparation and submission of regulatory filings, particularly Abbreviated New Drug Applications (ANDAs) and post-approval submissions. The role also involves cross-functional collaboration to ensure timely and compliant product approvals. We are seeking...
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Regulatory Affairs Sr Associate
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Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...
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Leading Regulatory Affairs Specialist
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Senior Regulatory Affairs Professional
3 weeks ago
We are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.
- Preparation, tracking, reporting, and archiving US regulatory documentation
- Management of Ad Promo regulated data
- Label change updates and implementation process management
- Logo, package component labeling (PCL), and important safety information (ISI) updates
- Digital labeling management and performance tracking for label change implementation
- Proficiency in MS Office applications, including Excel formulas and pivot tables
- Technical editing and proofreading with infographic creation and slide design capabilities
- Veeva PromoMats experience for Electronic Common Technical Documents (eCTD) compliance package creation
- FDA eCTD publishing tool expertise and knowledge of the US Medical, Legal, and Regulatory (MLR) review process within Veeva PromoMats
