Regulatory Compliance Manager
2 months ago
Responsibilities and Requirements: Manager of Regulatory Compliance will support the Sr. Director of Regulatory Process and Compliance in maintaining client's compliance with regulatory requirements. This role will focus on assisting with the operational aspects of compliance activities, ensuring regulatory documentation is well-maintained, and supporting continuous compliance initiatives. Assist in providing hands-on support during regulatory inspections and internal audits. Ensure compliance-related documentation is organized, current, and readily accessible. Define, manage and maintain regulatory compliance metrics and systems in collaboration with the Sr. Director. Assist in identifying trends in recent regulatory inspections and translate these into recommendations to improve inspection preparedness. Support the development and delivery of compliance education programs for employees at all levels. Manage GRS training curricula and LMS training metrics in collaboration with GRS line managers. Assist in managing the GRS CAPA framework, providing support and follow-ups as needed. Monitor local and global compliance trends and report emerging regulatory issues. Assist in preparing reports and summaries for compliance evaluations and inspections. Collaboration and Solutions. Collaborate with R&D and Supply Chain departments to address operational quality and regulatory issues. Provide support in developing and implementing solutions.
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Regulatory Compliance Manager
3 weeks ago
South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full timeRegulatory Compliance RoleAs a key member of the Katalyst Healthcares & Life Sciences team, the Regulatory Compliance Manager will play a vital role in ensuring the company's compliance with regulatory requirements. The successful candidate will support the Sr. Director of Regulatory Process and Compliance in maintaining client compliance and will be...
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Regulatory Lead
1 month ago
South Plainfield, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission). ct as the point of contact with regulatory agencies. Provide guidance on local mechanisms to optimize product development and regulatory approvals. Plan and manage local regulatory submissions in compliance with corporate...
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Global Regulatory Strategist
3 weeks ago
South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Global Regulatory StrategistKatalyst Healthcares and Life Sciences is seeking a highly skilled Global Regulatory Strategist to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies for our Oncology products.Key Responsibilities:Develop global or US...
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Sr Compliance and Regulatory Specialist
19 hours ago
Somerset, NJ, United States Joulé Full timeTitle: Sr. Compliance and Regulatory Specialist A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: * Bachelor's degree with at least 5+ years of experience working in...
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Regulatory Affairs Lead
3 weeks ago
Ewing, NJ, United States Church & Dwight Full timeJob Summary:Church & Dwight is seeking a highly skilled Regulatory Affairs Lead to join our Global Compliance team. As a key member of our team, you will be responsible for ensuring compliance with applicable regulations and standards for our medical devices globally.Key Responsibilities:Support the C&D Drug, Dietary Supplement/NHP and Cosmetic Auditing &...
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Regulatory Affairs Specialist
4 weeks ago
Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeSenior Regulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our products with global regulations.Key Responsibilities:Interpret and apply federal, state,...
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Regulatory Affairs Specialist II
4 weeks ago
Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Regulatory Affairs Specialist IIJob Summary:The Regulatory Affairs Specialist II will be responsible for coordinating and facilitating post-market regulatory programs, supporting the IA business units in meeting global registration requirements, and ensuring compliance with federal, state, and international regulations.Key...
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Credentialing Specialist
4 weeks ago
Morristown, NJ , USA, United States APN Software Services Full timeCredentialing Specialist Job SummaryWe are seeking a skilled Credentialing Specialist to join our team at APN Software Services. The successful candidate will be responsible for enforcing regulatory compliance and quality assurance in our credentialing process.Key Responsibilities:Ensure compliance with relevant regulatory requirements and industry...
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Regulatory Affairs Manager
3 weeks ago
South San Francisco, California, United States Biogen Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Biogen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and implement regulatory strategies to support product development and commercializationCollaborate...
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Regulatory Affairs Specialist
3 weeks ago
Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeJob Summary:As a Senior Regulatory Affairs Specialist at Katalyst Healthcares and Life Sciences, you will play a critical role in supporting global registrations by interpreting federal/state/international regulations and advising on compliance strategies. You will be responsible for investigating and resolving compliance problems, auditing policies and...
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Quality Auditor, Regulatory
2 months ago
Plainfield, United States MD Logistics Full timeAt MD Logistics, we are passionate about services we provide and the impact we have on our world. Our team of experienced professionals designs tailored planning services to deliver medications to patients. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun...
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Senior Manager Regulatory Affairs
3 weeks ago
US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full timeUnlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...
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Senior Manager, Quality Assurance
3 weeks ago
South Plainfield, New Jersey, United States PTC Therapeutics Full timeJob SummaryThe Senior Manager, Quality Assurance will be responsible for managing GxP Quality Assurance functions with an emphasis on Good Clinical Practice (GCP) compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to...
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Clinical Data Manager
3 weeks ago
South Plainfield, New Jersey, United States Lifelancer Full timeKey Responsibilities:Lead the data management process for clinical trials, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to design and implement data management strategies.Develop and maintain data management plans, including data validation, edit checks, and data transfer specifications.Provide oversight and...
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Clinical Data Manager
4 weeks ago
South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeClinical Data Manager **Key Responsibilities** As a Clinical Data Manager at Katalyst Healthcares and Life Sciences, you will serve as the primary liaison between our company and Contract Research Organizations (CROs) for data management. Your expertise will be instrumental in providing support and oversight to the CRO Data Management team, ensuring...
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Regulatory Affairs Specialist
4 weeks ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Senior Manager, Quality Assurance
3 weeks ago
South Plainfield, New Jersey, United States PTC Therapeutics Full timeJob Description Summary:The Senior Manager, Quality Assurance - GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP) compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and...
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Quality Assurance Manager
3 weeks ago
South Plainfield, New Jersey, United States Kashiv BioSciences LLC Full timeJob SummaryThe Quality Assurance Manager at Kashiv BioSciences LLC is responsible for maintaining the company's quality management system. This role oversees and directs the activities of the QA organization, ensuring compliance with cGMPs and regulatory requirements. The ideal candidate will have a thorough knowledge of laboratory practices, including...
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Compliance and Risk Management Specialist
4 weeks ago
Voorhees Township, NJ , USA, United States Utilities One Full timeJob Title: Compliance and Risk ManagerCompany Overview:Utilities One is a leading provider of comprehensive infrastructure solutions for the telecommunications industry. Our company offers a full suite of services to support infrastructure projects, providing end-to-end solutions to our valued clients.We are committed to excellence, integrity, and innovation...
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Senior Compliance Auditor
4 weeks ago
South Jordan, Utah, United States Merrick Bank Full timeJob SummaryMerrick Bank is seeking a highly skilled Senior Compliance Auditor to join our Internal Audit team. As a key member of our team, you will be responsible for assisting the VP Internal Audit Manager in planning, performing, and reporting on a comprehensive risk-based Internal Audit Plan covering all business units, departments, and functions...