
Senior Regulatory Compliance Specialist
2 weeks ago
Regulatory Affairs Manager
Job DescriptionAs a key member of our team, you will be responsible for managing CMC regulatory activities and ensuring compliance with regulatory requirements.
You will lead cross-functional teams in the preparation, review, and filing of ANDAs, as well as oversee the compilation and submission of Annual Reports, amendments, and deficiency responses. Your role will also involve interfacing with production/plant teams and staying up-to-date with evolving USFDA regulations.
Key Responsibilities- Capture Clinical Trial Document Control procedures to ensure integrity and consistency across all functions
- Evaluate Quality Data management processes to enhance control and efficiency throughout the quality function
- Design and Implement process improvements that meet changing needs of business and industry
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Senior Regulatory Compliance Specialist
1 week ago
Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Regulatory Specialist: US FDA Submissions",">Lead and oversee the preparation, review, and submission of CMC regulatory activities for USFDA submissions.Collaborate with cross-functional teams to gather required documentation and data for regulatory compliance.Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents,...
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Regulatory Compliance Specialist
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Senior Regulatory Compliance Specialist
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Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time US$ 90,000 - US$ 1,15,000Business Compliance Specialist RoleJob Description:The role of a Business Compliance Specialist is pivotal in ensuring that companies adhere to all necessary regulations and laws. This entails managing federal business registrations, obtaining Employer Identification Numbers (EIN), IRS filings, and compliance with state-specific requirements.
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Quality Assurance Compliance Specialist
1 week ago
Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000Job Title: Quality Assurance Compliance SpecialistKey Responsibilities:We are seeking a detail-oriented Regulatory Compliance Specialist with 10-15 years of experience in quality assurance and compliance in a pharmaceutical industry setting to join our team.The ideal candidate will have expertise in validation methodologies, regulatory guidelines (US FDA,...
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Senior Regulatory Compliance Specialist
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Regulatory Monitoring Specialist
7 days ago
Rajahmundry, Andhra Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000The role of Regulatory Monitoring Specialist is pivotal in ensuring our organization stays ahead of the curve in regulatory compliance. The successful candidate will be responsible for monitoring global and regional regulatory bodies, staying up-to-date with new and updated regulations, consultation papers, and guidance.Key responsibilities...
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Compliance Specialist
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Rajahmundry, Andhra Pradesh, India beBeeOperational Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job OverviewThe KYC Operations Manager is a mid-level leadership role that oversees the delivery of comprehensive Anti-Money Laundering (AML) monitoring, governance, oversight, and regulatory reporting. The key objective is to design, implement, and manage a robust internal Know Your Customer (KYC) program for a multinational organization.Manage KYC...
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Senior Regulatory Affairs Specialist
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Rajahmundry, Andhra Pradesh, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000Global Regulatory Affairs SpecialistWe are seeking a detail-oriented professional to support end-to-end submissions for global markets. The ideal candidate will have exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Document Preparation: Prepare Variation documents and/or evaluate...
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Senior Power Sector Regulatory Expert
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Rajahmundry, Andhra Pradesh, India beBeeRegulatory Full time ₹ 36,00,000 - ₹ 40,00,000Regulatory Specialist Job OverviewWe are seeking an experienced professional to fill the role of Regulatory Specialist with a strong background in the power sector. The ideal candidate will have expertise in regulatory frameworks and a proven track record of working within them.Main Responsibilities:Draft, compile, and submit regulatory petitions, compliance...