Regulatory Coordinator
4 weeks ago
• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations
• Contribute to Module #1 documents including FDA forms and cover letters for maintenance/non-maintenance submissions with management oversight
• Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities
• Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable
• Independently manage the user fee registration requests. Independently manage and execute drug shipment ticket review process (US)
• In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc.
• Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities
• Where appropriate, participating in kick-off meetings for NDA/IND annual reports and QC of NDA annual reports from previous versions (US). Where appropriate, perform QC of approved label versus previous versions with adequate management oversight
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Regulatory Coordinator
1 month ago
Hyderabad, Telangana, India Novartis Full time394724BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...
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Regulatory
4 weeks ago
Hyderabad, India Axis Energy Ventures India Full time**Location**:Hyderabad **Essential Duties & Responsibilities**: - Identify new business opportunities like Green Hydrogen, Storage etc. and study the tender documents pertaining to the same. - Prepare summaries of tenders and identify important clauses having techno-commercial impact. - Attend pre bid meetings organized by Project implementing Agencies and...
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Global Program Regulatory Manager- LCM
1 month ago
hyderabad, India Novartis Full timeYour responsibilities include but not are limited to:• Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or...
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Regulatory Innovation Associate
2 weeks ago
hyderabad, India Lifelancer Full timeAbout the job The Regulatory Innovation Associate plays a critical role in the development of regulatory services technology products to drive innovation and differentiation. Under general supervision, provides regulatory expertise and technical support for regulatory technology innovation initiatives. Essential Functions: Navigate through the Health...
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Senior Regulatory Affairs Associate
1 month ago
Hyderabad, India Parexel Full timeRegulatory Affairs LabelingBachelor’s Degree plus at least 5 to 8 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,...
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Senior Regulatory Affairs Associate
4 weeks ago
Hyderabad, Telangana, India Parexel Full timeRegulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 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...
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Senior Regulatory Affairs Associate
1 month ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’s Degree plus at least 5 to 8 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...
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Senior Regulatory Affairs Associate
4 weeks ago
hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Regulatory Affairs Labeling Bachelor’s Degree plus at least 5 to 8 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...
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Clinical Research Coordinator
1 week ago
Hyderabad, India Learning Labb Research Institute Full timeWe are seeking a motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. As a Clinical Research Coordinator, you will play a crucial role in the planning, implementation, and coordination of clinical research studies. You will work closely with principal investigators, study participants, and other healthcare professionals to...
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hyderabad, India Carrier Full timeCountry: India Location: Building No: 12C, Floor 9,10,11, Building No: 12B -Stilt floor, Raheja Mindspace, Cyberabad, Madhapur, Hyderabad - 500081, Telangana, India Job Title – Test & Validation Preferred Location - Hyderabad, India Full time/Part Time - Full Time EXP – 6 Years - 11 Years Build a career with confidence! ...
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Hyderabad, India Carrier Full timeCountry: India Location: Building No: 12C, Floor 9,10,11, Building No: 12B -Stilt floor, Raheja Mindspace, Cyberabad, Madhapur, Hyderabad - 500081, Telangana, India Job Title – Test & Validation Preferred Location - Hyderabad, India Full time/Part Time - Full Time EXP – 6 Years - 11 Years Build a career with confidence! Carrier...
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Clinical Project Coordinator
4 weeks ago
Hyderabad, India Makrocare Full timeCompany Description **MakroCare |** **_A MakroGroup Company_**MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...
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Ra Coordinator
4 weeks ago
Hyderabad, Telangana, India Novartis Full time390691BR **RA Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...
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Pyp Coordinator
4 weeks ago
Hyderabad, India New York Academy Full timeThe PYP Coordinator is a key and senior member of staff who works closely with all members of the primary team; academy administrators, programme coordinators, lead teachers, and co teachers to coordinate, lead and ensure effective curriculum planning and recording. The PYP coordinator is a member of the Pedagogical leadership team. The PYP coordinator is...
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hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Project Coordinator
6 days ago
Ameerpet, Hyderabad, Telangana, India vashishta systems Full timeJob Location: Hyderabad - _**Bachelor's degree in engineering, construction management, or a related field.**_ - _**Must be strong in MS Office**_ **Key Responsibilities**: - **Project Planning**: Assist in the development of project plans, timelines, and budgets. Coordinate with stakeholders to define project scope, objectives, and deliverables. -...
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Document Coordinator, Global Trial Acceleration
1 month ago
Hyderabad, Telangana, India Bristol-Myers Squibb Full time**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Associate Buying Coordinator-
1 month ago
Hyderabad, Telangana, India Wells Fargo Full timeJob Requirements Job Title: Associate Buying CoordinatorCompany Name: Wells FargoLocation: Hyderabad, TelanganaSalary: ₹7,24,723 per yearEmployment Type: Full-timeJob Description:Wells Fargo is seeking an enthusiastic and detail-oriented Associate Buying Coordinator to join our team in Hyderabad. As an Associate Buying Coordinator, you will play a vital...
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Commercial Banking Portfolio Coordinator
1 week ago
Hyderabad, India WELLS FARGO BANK Full time**About this role**: Wells Fargo is seeking a Commercial Banking Portfolio Coordinator... **In this role, you will**: - Review credit information of loans for companies and industries - Respond to customer inquiries, generate status reports for management or bankers and contact available sources of information - Perform moderately complex credit...