Regulatory Affairs Intelligence Mgr
2 weeks ago
Job Summary: Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence.
Key Activities: Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence. Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback. Effectively communicates regulatory requirements to Regulatory Affairs staff. Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Applies tools and systems to deliver agreed intelligence objectives. Communicates progress and escalates issues impacting delivery of intelligence outputs. Provides suggestions for improvement of processes, systems and tools employed within the function.
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Regulatory Affairs Intelligence Mgr
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Intelligence Mgr Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance...
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Regulatory Affairs Intelligence Mgr
4 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category ClinicalGlobal Regulatory Policy and Intelligence engages regulators industry and professional associations and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgens goals and priorities Regulatory Intelligence for the GRAAS organization enables fast ...
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Regulatory Affairs Mgr
2 weeks ago
Hyderabad, Telangana, India Amgen Full timeJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas...
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Regulatory Writing Mgr
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Writing Mgr Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Global Regulatory Writing ManagerRole Name: Global Regulatory Writing ManagerDepartment Name: Global Regulatory Affairs & Strategy (GRAAS)Role GCF: 5Hiring Manager Name: Jennifer Vande WegheAbout...
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Regulatory Writing Mgr
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Writing Mgr Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT...
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Regulatory Affairs Director
3 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Corporate Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece.In the initial phase, the office will focus on Regulatory Affairs, supporting the...
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Regulatory Affairs Director
3 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Global Services Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece and subsidiaries in Europe.In the initial phase, the office will focus on Regulatory...
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Regulatory Affairs Director
2 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Global Services Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece and subsidiaries in Europe.In the initial phase, the office will focus on Regulatory...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Specialist Job Location: Hyderabad, Telangana, India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Medtronic Full timeCareers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India Medtronic Full timeCareers that Change LivesCollaborate and partner with Design QA R D Sustaining Engineering Clinical Affairs Marketing and Operations Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met Responsible for supporting the needs of the MEIC with regulatory support for research and...
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Regulatory Affairs Assistant
2 days ago
Hyderabad, Telangana, India Gamut HR Solutions Full timeCompany OverviewGamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at http://gamuthrsolutions.com/.Job OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join...
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Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youxe2x80x99ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the LifeRegulatory Affairs Specialist-IICareers that Change LivesCareer growth and development is...
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Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the LifeRegulatory Affairs Specialist-IICareers that Change LivesCareer growth and development is about...
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Regulatory Writing Mgr
2 weeks ago
Hyderabad, Telangana, India Amgen Full time**Global Regulatory Writing Manager****Role Name:** Global Regulatory Writing Manager**Department Name:** Global Regulatory Affairs & Strategy (GRAAS)**Role GCF:** 5**Hiring Manager Name:** Jennifer Vande Weghe**ABOUT AMGEN**Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Specialist - 2 Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Associate At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down...
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Regulatory Affairs Manager
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Manager Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and...
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Regulatory Affairs Analyst
3 weeks ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full timeJob DescriptionWe are looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals.This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP. Collaboration with European Regulatory authorities and internal...
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Global Regulatory Affairs Specialist
2 days ago
Hyderabad, Telangana, India Novartis Full timeRegulatory Affairs Role:In this critical role, you will be responsible for ensuring that Novartis' products comply with regulatory requirements. As a Regulatory Compliance Manager, you will develop and implement global CMC regulatory strategies, lead global CMC submission activities, and collaborate with cross-functional teams to ensure alignment and...
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Manager, Regulatory Affairs
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Manager, Regulatory Affairs - CMC Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job DescriptionManager, Regulatory Affairs - CMCThe incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure...