Regulatory Labelling Specialist
1 month ago
As a Regulatory Labelling Specialist at Biocon Biologics, you will be responsible for creating and implementing labelling strategies for health authority interactions and handling queries from country organizations. You will work closely with the CFT team to ensure artwork management for initial submissions and commercial launches.
Key responsibilities include:
- Developing and maintaining labelling strategies for assigned programs and products
- Coordinating with external vendors for translation services
- Preparing and reviewing SPL documents for initial submissions and labelling responses
- Managing labelling team members and ensuring quality control
Required qualifications include a degree in pharmacy or a related field, as well as a minimum of 7 years of experience in regulatory labelling, with a focus on EU labelling.
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Regulatory Labelling Specialist
2 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timeJob Title: Regulatory Labelling ManagerAbout the Role:We are seeking an experienced Regulatory Labelling Manager to join our team at Biocon Biologics. The successful candidate will be responsible for creating and implementing labelling strategies for health authority interactions and handling labelling queries for assigned programs and products.Key...
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Regulatory Labeling Expert
7 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timeJob DescriptionWe are seeking a highly skilled Regulatory Labelling Manager to join our team at Biocon Biologics. In this role, you will be responsible for creating labeling strategies for health authority interactions and handling queries related to assigned programs and products.The successful candidate will have a strong background in regulatory labelling...
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Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeParexel is seeking a highly skilled Senior Regulatory Affairs Associate- Labeling to join our team. In this role, you will play a critical part in ensuring compliance with key labeling regulations and guidelines.About the Role:We are looking for an individual with 4+ years of experience in drug development, specifically in labeling, product package...
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PV Labeling Professional
3 weeks ago
Bengaluru, Karnataka, India Teva Pharmaceuticals Full timeAbout the OpportunityWe are seeking a skilled Pharmacovigilance Labeling Specialist to join our team at Teva Pharmaceuticals. As a key member of our Pharmacovigilance department, you will be responsible for preparing and maintaining labeling lists for Teva products.Key ResponsibilitiesCoordinate and maintain labeling lists for Teva products, analyzing...
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Regulatory Affairs Specialist
1 month ago
Bengaluru, Karnataka, India Baxter Full timeAbout VantiveVantive is a new company built on the legacy of Baxter, a leading healthcare company. We are on a mission to revolutionize kidney care and other vital organ support.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for supporting all regulatory activities...
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Senior Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India Parexel Full timeAbout This RoleParexel seeks a highly skilled Senior Regulatory Affairs Associate- Labeling to join our team. The ideal candidate will have a strong understanding of key labeling regulations and guidance, with experience in label development (CCDS, USPI, packaging) and research and creation of comparator labeling documents.Key ResponsibilitiesLabel...
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Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Sphera Full timePrimary FunctionThe ideal candidate will cost-effectively prepare regulatory-compliant Safety Data Sheet (SDS) documents for international customers. This involves effectively authoring regulatory compliant SDS/Labels for external customers across various countries and regions.Key ResponsibilitiesAuthor regulatory compliant SDS/Labels for external...
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Regulatory Compliance Specialist
1 month ago
Bengaluru, Karnataka, India Sphera Full timeAs a key member of our team at Sphera, you will play a critical role in ensuring the accuracy and compliance of Safety Data Sheets (SDS) for our international customers. Your primary function will be to prepare regulatory-compliant SDS documents that meet the requirements of various countries, including the US, EU, CA, and others.Key Responsibilities:Author...
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Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Description:Key Responsibilities:Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead...
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Data Labeler Specialist
4 weeks ago
Bengaluru, Karnataka, India CloudHire Full timeJob Overview:CloudHire is seeking a highly skilled Data Labeler to join our team. As a Data Labeler, you will play a crucial role in refining and labeling large datasets for our machine learning models.Key Responsibilities:• Analyze and label large datasets with precision and accuracy• Refine labeled data to ensure high-quality results• Utilize...
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SPL Specialist: Regulatory Compliance Expert
4 weeks ago
Bengaluru, Karnataka, India Genpact Full timeJob Description: We are seeking a highly skilled SPL Specialist to join our team at Genpact. As a key member of our regulatory compliance team, you will be responsible for creating and managing FDA-required Structured Product Labeling (SPL) documents for our clients.Key Responsibilities:Creation and management of FDA-required SPL documents, including...
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Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Description:Key Responsibilities:Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead...
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Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India Philips Full timeAbout the RolePhilips is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW.Key...
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Bengaluru, Karnataka, India Gumazing Full timeWe are seeking an experienced Global Regulatory Compliance Specialist to ensure our supplement products meet international regulatory standards. As a key member of our team, you will serve as the main point of contact between our factories and distributors for regulatory matters.Key Responsibilities:Liaison: Establish and maintain effective relationships...
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Regulatory Affairs Lead
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeAbout the RoleAt Philips, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and RoW.Key ResponsibilitiesDevelop and execute...
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Regulatory Affairs Expert
4 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Sr. Regulatory Affairs SpecialistYou will be an integral member of our Clinical Informatics Regulatory Affairs team, influencing and shaping the regulatory capabilities for future success of Philips.Your Key Responsibilities:Ensure safe and effective products/solutions are brought to market on time and sustained throughout their lifecycle via...
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Bengaluru, Karnataka, India Baxter Full timeBaxter is a leading global innovator of medical products, with a legacy spanning nearly 70 years. Our journey towards separating the $5B Kidney Care segment into a standalone company has brought about an exciting opportunity to revolutionize kidney care and other vital organ support.As a Regulatory Affairs Specialist for Kidney Care Product Development, you...
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Regulatory Reporting Specialist
4 weeks ago
Bengaluru, Karnataka, India State Street Full timeJob Title: Regulatory Reporting SpecialistThe Regulatory Reporting Specialist at State Street will be responsible for preparing and submitting regulatory reports to the Federal Reserve and other US regulatory bodies. This includes financial condition and income reports, regulatory capital reports, and Treasury International Capital (TIC) reports. The...
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Pharmacovigilance Specialist, Labeling Lists
3 weeks ago
Bengaluru, Karnataka, India Teva Pharmaceuticals Full timeThe OpportunityAs a Labeling Lists Coordinator, you will be responsible for preparing automatic labeling lists based on Reference Safety Information (RSI).How You'll Spend Your DayCoordinate and maintain labeling lists for Teva products, analyzing reported adverse events in relation to RSI using medical judgment and understanding of the event's...
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Regulatory Compliance Specialist
4 weeks ago
Bengaluru, Karnataka, India F335 Deutsche India Private Limited, Bangalore Branch Full timeJob Summary F335 Deutsche India Private Limited, Bangalore Branch seeks a highly skilled Regulatory Compliance Specialist to join its team. As an Associate Financial Services Analyst, you will be responsible for ensuring the bank's adherence to regulatory requirements and providing excellent client support. Key Responsibilities As a Regulatory Compliance...