
Executive - Regulatory Affairs (Europe and UK Market)
4 days ago
Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Europe and UK market for CMC and labelling aspects.
To collate and compile new application & life cycle management CTD dossier modules from M1 to M5 for Europe and UK.
Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.
Develop and implement regulatory CMC strategies to support new MAA and post-approval changes (PACs), variations, and life cycle activities.
Co-ordinate with cross functional teams for document request, review, required for regulatory submission.
Upload and publish the documents in eCTD software required for regulatory submission.
Arranging and coordinating trainings within departments.
Critically review documentation intended for submission for internal consistency
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Senior Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per yearDescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...
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Regulatory Affair Manager
2 weeks ago
Bengaluru, Karnataka, India Futura Surgicare Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPosition Title: Regulatory Affairs & QA ManagerDepartment: Quality & Regulatory AffairsLocation: BangaloreRole OverviewThe Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485,...
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Regulatory Affairs
7 days ago
Bengaluru, Karnataka, India Surgeway Biosciences Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJOB TITLE :Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training...
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Regulatory Affairs Executive
1 week ago
Bengaluru, Karnataka, India, Karnataka Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...
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Regulatory Affairs Lead Specialist
1 week ago
Bengaluru, Karnataka, India GE Healthcare Private Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per yearLead Specialist, Regulatory Affairs - WHXR Job Description SummaryJoin GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to...
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Regulatory & Liaisoning Affairs Officer
4 days ago
Bengaluru, Karnataka, India Enerparc Energy Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob DescriptionAbout Company:Enerparc AG is a global expert in developing, engineering, building, and operating ground mount as well as roof mount photovoltaic (PV) systems. As an EPC contractor, our company has connected over 3400 MW of solar systems to electricity grids. With local presence in all active solar markets like Europe, Middle East & Asia, we...
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Senior Specialist _ Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time ₹ 12,00,000 - ₹ 36,00,000 per yearYour Role: To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables Update and review CMC specific documentation, incl. coordination with countries to compile local CMC...
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Program Manager, Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India GE Healthcare Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearProgram Manager, Regulatory Affairs, Maternal Infant Care Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of...
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Senior Specialist _ Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India Merck Healthcare Full time ₹ 10,00,000 - ₹ 25,00,000 per yearWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
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Director - Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India GE Healthcare Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearDirector - Regulatory Affairs ISA Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets internal and external business...