Regulatory Data Management Professional
2 days ago
We are seeking a highly skilled Regulatory Data Specialist to play a key role in ensuring our IT systems meet regulatory requirements and industry best practices.
The successful candidate will have experience managing and maintaining IT systems, interpreting and implementing regulatory requirements, and assisting in planning, tracking, and executing departmental projects.
Requirements:- 5+ years of 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.
- Advanced knowledge of Veeva Vault.
- Familiarity with global regulatory processes and standards.
- Proficiency in Agile methodologies, including Scrum or Kanban.
- Bachelor's degree and 2 years of directly related experience.
- Associate's degree and 6 years of directly related experience.
- High school diploma / GED and 8 years of directly related experience.
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Regulatory Affairs Professional
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Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000About the roleWe are seeking a seasoned Regulatory Affairs professional to manage end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions.Manage cross-functional teams to collect required data and documentation for timely regulatory submissions.Compile CMC documentation in compliance with FDA...
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Manager - Regulatory Affairs
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Hyderabad, Telangana, India Amgen Full timeJoin Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...
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Senior Regulatory Affairs Professional
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Hyderabad, Telangana, India beBeeregulatory Full time ₹ 18,00,000 - ₹ 24,00,000Regulatory Affairs Senior AssociateWe are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Associate. This role will involve assisting in the development and implementation of regulatory strategies across all product brands.Preparation, tracking, reporting, and archiving US regulatory documentationManagement of Ad Promo...
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Insurance Regulatory Compliance Professional
6 days ago
Hyderabad, Telangana, India beBeeRegulatoryCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Compliance SpecialistThis role requires a detail-oriented professional with expertise in regulatory compliance. The ideal candidate will have extensive knowledge of insurance regulations and be skilled in data validation, monitoring, and record-keeping.The Compliance Specialist will ensure timely submission of regulatory filings, validate health and...
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Data Associate – Regulatory Information
4 weeks ago
Hyderabad, Telangana, India ArtiXio Full timeAbout Us:At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation.Key...
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Data Associate – Regulatory Information
4 weeks ago
Hyderabad, Telangana, India ArtiXio Full timeAbout Us:At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation.Key...
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Data Associate – Regulatory Information
4 weeks ago
Hyderabad, Telangana, India ArtiXio Full timeAbout Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation. Key...
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Data Associate – Regulatory Information
4 weeks ago
Hyderabad, Telangana, India ArtiXio Full timeAbout Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation.Key...
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Regulatory Data
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Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionRoles & Responsibilities:- System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, 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...
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Regulatory Affairs Manager
3 days ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionThe RA CMC Manager is responsible for the execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products.The RA CMC Manager is responsible for communicating the...
