Regulatory Data
1 week ago
Career Category RegulatoryThe Regulatory Data Systems Senior Associate will be responsible for interpreting and executing business requirements based on a combination of industry best practice and Amgen regulatory processes This role involves optimizing complex data systems supporting the health authority submission process while ensuring compliance with regulatory regulations and guidance The ideal candidate will have a strong background in system analysis and data science AI in a regulated industry Roles Responsibilities Data Administration AI Optimize and maintain the organization s complex data models ensuring they are integrated efficient and compliant with regulatory requirements Regulatory Business Analysis Interpret and implement regulatory requirements ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices Project Coordination Assist in planning tracking and executing departmental projects and initiatives Stakeholder Communication Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates Required Knowledge and Skills Strong interpersonal and teamwork skills with the ability to interact with business users technical IT groups project managers senior management outsourced service providers and vendors 5 years experience as a business analyst with command of business analysis techniques tools as well as SDLC agile systems development methodologies Excellent oral and written communication skills able to organize and present ideas in a convincing and compelling manner Ability to operate effectively in a matrix environment team player yet able to work independently with minimal direction Familiarity with GxP requirements and systems validation Life Sciences Biotech or pharmaceutical industry experience Preferred Knowledge and Skills Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards Proficiency in Agile methodologies including Scrum or Kanban to enhance collaboration efficiency and adaptability within an Agile work environment Basic Education and Experience Bachelors degree and 2 years of directly related experience Associates degree and 6 years of directly related experience High school diploma GED and 8 years of directly related experience Preferred Education and Experience Practical experience with regulatory data standards such as IDMP 5 years experience in data management machine learning or related fields
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Regulatory Writer
1 week ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
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Regulatory System Associate
1 week ago
Hyderabad, Telangana, India Haleon Full timeThe purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used to prepare...
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Expert Regulatory Writer
1 week ago
Hyderabad, Telangana, India Novartis Full time392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...
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Sr Regulatory Coordinator
5 days ago
Hyderabad, Telangana, India Novartis Full timeSummary The Senior Regulatory Coordinator Sr RC works under close supervision to support for development including line extension and maintenance projects through development registration and approval including post approval commitments To maximize operational effectiveness Collaborate with RA GDD Development Units RA GDD CMC Regional...
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Only 24h Left Regulatory Data
3 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory The Regulatory Data Systems Associate will be responsible for interpreting and executing business requirements based on a combination of industry best practice and Amgen regulatory processes This role involves optimizing complex data systems supporting the health authority submission process while ensuring...
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Regulatory Reporting Assurance
3 weeks ago
Hyderabad, Telangana, India State Street Full timeThe Regulatory Reporting Assurance RRA department is a management assurance team in the Controllers Organization within Corporate Finance The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting including Liquidity Reporting Basel Comprehensive Capital Analysis and Review ...
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Regulatory Reporting
2 weeks ago
Hyderabad / Secunderabad, Telangana, India Goldman Sachs Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Description We are looking for an Operations professional to work in the Regulatory Reporting team within Regulatory & Control Operations.Develop expert knowledge in Regulatory requirements, processes and systems across global jurisdictions Perform reconciliation and exception management as per the various Regulatory requirements Investigate and...
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Clinical Data Associate Ii
2 weeks ago
Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full timeClinical Data Associate II Statistics Data Corporation SDC a specialized contract research organization CRO headquartered in Arizona delivering top-tier clinical trial services to pharmaceutical biologic and medical device diagnostic companies since 2005 SDC providing a technology enabled service offering to provide clients with both clinical...
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Regulatory Affairs Manager
2 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
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Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases and make people s lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and...
