Regulatory Compliance Specialist
2 weeks ago
This is a supervisory position that requires effective leadership and communication skills to manage a team and ensure the efficient upload and management of electronic documents in the eTMF system.
The successful candidate will be responsible for managing a team of eTMF Specialists, allocating workload, overseeing quality reviews, training and developing team members, and prioritizing the book of work.
The ideal candidate will have a strong background in regulatory compliance and clinical trial documentation, with experience in directly managing, leading, and developing employees.
They will also possess comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management, as well as extensive knowledge and application of ALCOA Plus standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (ICH-E6).
The successful candidate will be able to interact and communicate effectively at all levels of the organization, with strong leadership and people management skills.
They will also be able to prioritize work and assess risk to meet the needs of the organization, and be adaptable and able to modify personal and organizational work style to meet the needs of the business.
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Regulatory Compliance Specialist
1 week ago
Hyderabad, Telangana, India Velocity Clinical Research, Inc. Full timeJob Overview:Velocity Clinical Research, Inc. is a leading research site organization dedicated to delivering excellence in patient care and high-quality data. As a Senior Regulatory Specialist, you will play a critical role in ensuring the success of our clinical trials by preparing and maintaining complete and accurate regulatory documents.Key...
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Regulatory Compliance Specialist
7 days ago
Hyderabad, Telangana, India Novartis Full time**Job Overview:**We are seeking a Regulatory Compliance Specialist to join our Quality Operations team at Novartis. As a key member of our team, you will be responsible for ensuring regulatory compliance and adherence to Novartis policies and procedures.Main Responsibilities:Manage different types of change control, including product stewardship,...
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Regulatory Compliance Specialist
6 days ago
Hyderabad, Telangana, India NOVARTIS Full timeJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at NOVARTIS. The ideal candidate will have a strong background in Quality Assurance and a deep understanding of GxP systems.The successful candidate will be responsible for providing quality oversight of project and operational activities, ensuring compliance with...
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Regulatory Compliance Expert
6 days ago
Hyderabad, Telangana, India TopGear Consultants Private Limited Full timeAbout the RoleThis is an exciting opportunity to join TopGear Consultants Private Limited as a QA Specialist (QMS Activities). As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and implementing QMS processes effectively.Responsibilities:Regulatory ComplianceEnsure adherence to cGMP, FDA, ICH guidelines,...
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Regulatory Compliance Specialist
5 days ago
Hyderabad, Telangana, India Bristol-Myers Squibb Full timeTransforming Lives through ScienceBristol-Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. Our work goes beyond ordinary, and we empower our employees to apply their individual talents and unique perspectives in an inclusive culture. As a Submission Specialist, you will be part of the...
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High Salary: Regulatory Compliance Expert
1 week ago
Hyderabad, Telangana, India Synchrony Full timeJob SummaryThe Senior Specialist, External Inquiries will be responsible for increasing compliance and governance across various processes within External Inquiries (EI). This role will be critical in ensuring the External Inquiries function is effectively meeting regulatory and compliance requirements for credit bureau, ECOA, and other EI processes.The...
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Regulatory Compliance Expert II
2 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAbout the RoleWe are seeking a skilled Regulatory Compliance Expert II to join our team. As an MDR Vigilance Specialist II, you will be responsible for ensuring complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
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Regulatory Affairs Specialist
1 week ago
Hyderabad, Telangana, India Hetero Full timeAbout HeteroHetero is a global pharmaceutical company dedicated to delivering high-quality medicines and innovative solutions to patients worldwide.Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our team in this critical role. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with...
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Compliance Specialist
7 days ago
Hyderabad, Telangana, India People tech Full timeJob DescriptionWe are seeking a highly skilled Compliance Specialist to join our team at People tech. This individual will be responsible for ensuring the regulatory compliance of our products across the entire product line.Key Responsibilities:Develop and implement strategies to ensure compliance with relevant regulatory requirements.Collaborate with...
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Software Development Specialist
3 days ago
Hyderabad, Telangana, India Medtronic Full timeAbout the RoleThis exciting opportunity is for a highly motivated and detail-oriented Software Development Specialist - Regulatory Compliance. You will work closely with our cross-functional team to design, develop, and test software for medical devices, ensuring compliance with regulatory requirements.ResponsibilitiesDesign and develop software for medical...
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Senior Regulatory Compliance Officer
6 days ago
Hyderabad, Telangana, India Velocity Clinical Research, Inc. Full timeJob DescriptionThe Senior Regulatory Specialist will be responsible for preparing and maintaining regulatory documents, leading the regulatory team, and ensuring compliance with regulatory requirements.Key Responsibilities:Prepare and submit regulatory documents, including protocols, informed consent forms, HIPAA authorizations, and amendments.Lead the...
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Senior Regulatory Compliance Specialist
6 days ago
Hyderabad, Telangana, India NOVARTIS Full timeAbout the OpportunityWe are seeking an experienced Regulatory CMC Associate Manager-II to join our team at NOVARTIS. In this role, you will be responsible for preparing and publishing REG CMC documentation for submissions to Health Authorities and interacting with Health Authorities on REG CMC questions to support new product or post-marketed launches.You...
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Regulatory Compliance Specialist
1 week ago
Hyderabad, Telangana, India Hetero Labs Limited Full timeHetero Labs Limited seeks a skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for the development of Active Pharmaceutical Ingredient (API) Drug Master Files (DMFs) in accordance with regulatory requirements.Key Responsibilities:Preparation and Compilation of DMFs: Ensure that DMFs are prepared and compiled in...
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Clinical Research Regulatory Specialist
6 days ago
Hyderabad, Telangana, India Velocity Clinical Research, Inc. Full timeAbout the RoleThe Senior Regulatory Specialist will be responsible for leading the regulatory team and ensuring compliance with ICH, GCP, and FDA regulations.Key Skills:Strong understanding of regulatory requirements and guidelines.Excellent communication and leadership skills.Ability to analyze complex data and make strategic decisions.Experience working in...
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Regulatory Compliance Professional
1 week ago
Hyderabad, Telangana, India Invesco Full timeAre you a detail-oriented and analytical individual with a passion for regulatory compliance? We are seeking a Regulatory Compliance Professional to join our team at Invesco.About the RoleThe ideal candidate will have a strong understanding of regulatory requirements and best practices in trade operations and financial reporting. You will be responsible for...
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Global Regulatory Compliance Professional
3 days ago
Hyderabad, Telangana, India Medtronic Full time**Job Summary:**The Regulatory Affairs Specialist II will be responsible for supporting the Global Operating Unit in ensuring compliance with regulatory requirements for medical devices. This includes preparing, reviewing, and filing premarket documents for global registrations, collaborating with business units and international regulatory affairs...
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Compliance Specialist
1 week ago
Hyderabad, Telangana, India People tech Full timeAbout the RoleAt People tech, we are seeking a skilled Compliance Specialist to join our team. This is an exciting opportunity for a motivated individual to work closely with cross-functional teams to ensure end-to-end compliance of certified products.Key Responsibilities:Regulatory Derivation & Deployment: Identify, interpret, and apply relevant regulatory...
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Regulatory Compliance Professional
2 weeks ago
Hyderabad, Telangana, India Capco Full timeRole Overview: Capco is seeking a Regulatory Compliance Professional to join our team.Responsibilities:The ideal candidate will have 8+ years of experience in regulatory compliance, credit risk management, and IFRS9 reporting.Ensure compliance with Basel 3 regulatory requirementsDevelop and implement effective credit risk management strategiesPrepare and...
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Global Regulatory Compliance Specialist
5 days ago
Hyderabad, Telangana, India Bristol-Myers Squibb Full timeJob SummaryThis position supports the planning, organization, and review of routine submissions for chemistry, manufacturing, and controls (CMC) and regulatory activities. The successful candidate will work closely with responsible parties to ensure high-quality submission documents and troubleshoot any issues that arise.The Senior Submission Specialist will...
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Regulatory Compliance Expert
3 days ago
Hyderabad, Telangana, India Medtronic Full timeJob OverviewWe are seeking a highly skilled Regulatory Compliance Expert to join our team. As a key member of our regulatory affairs department, you will play a vital role in ensuring the safe and effective use of our medical devices.Your primary responsibility will be to develop and implement regulatory strategies that meet the needs of our customers and...