Regulatory Compliance Manager
3 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
1 month ago
plainfield, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities 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...
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Regulatory Compliance Specialist
3 weeks ago
South Burlington, Vermont, United States OnLogic, Inc. Full time**About OnLogic, Inc.**We are a leading designer and manufacturer of industrial computers and hardware solutions for companies worldwide. Our mission is to create innovative products that help our customers achieve their goals.**Job Description:**As a Regulatory Compliance Specialist at OnLogic, you will play a critical role in ensuring our products meet the...
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Regulatory Compliance Specialist
3 weeks ago
Plainfield, New Jersey, United States NavitsPartners Full timeJob OverviewThe NavitsPartners team is seeking a highly skilled Regulatory Compliance Specialist to support the implementation of quality systems in the pharmaceutical industry. This role will involve collaboration with cross-functional teams and interaction with various documentation systems.About the RoleThis is a 12-month contract position, working on a...
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Regulatory Compliance Engineer
4 days ago
South San Francisco, California, United States Spirair, Inc. Full timeJoin Our Team as a Regulatory Compliance Engineer!Spirair, Inc. is a leader in the medical device industry, committed to delivering high-quality products that meet or exceed regulatory standards. As a Quality Engineer at Spirair, you will be responsible for supporting our Quality Management System, ensuring compliance with FDA regulations and industry...
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Regulatory Compliance Expert
3 weeks ago
South Bend, Washington, United States Pacific Seafood Full timeJob OverviewPacific Seafood, a family-owned organization, is seeking an experienced Regulatory Affairs Manager to support regulatory submissions and compliance efforts. As a key member of our Leadership team, this role involves collaborating with location leadership and regulatory agencies.The ideal candidate will have expertise in regulatory compliance,...
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Sr Compliance and Regulatory Specialist
1 month 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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Director, Regulatory Affairs
2 weeks ago
Parsippany, NJ, United States Ferring Pharmaceuticals Inc. Full timeJob Description: As a privately-owned biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first'...
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Regulatory Compliance Specialist
2 weeks ago
Bel Air South, Maryland, United States Bellisio Foods, Inc. Full timeAt Bellisio Foods, Inc., we are committed to delivering high-quality food products while ensuring the safety of our consumers. We are seeking a skilled Regulatory Compliance Specialist - Food Safety to join our team.Key Responsibilities:Implement and maintain standardized food safety policies and procedures to ensure compliance with regulatory...
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South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Regulatory Affairs Strategist for Oncology Product Development**Overview:**Katalyst Healthcares and Life Sciences is seeking a highly experienced Regulatory Affairs Strategist to join our team. As a key member of our Global Regulatory Strategy group, you will be responsible for developing and executing regulatory strategies for Oncology products...
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South San Francisco, California, United States Alumis Full timeJob OverviewAlumis Inc. is a pioneering precision medicines company dedicated to revolutionizing the lives of patients with autoimmune diseases. Despite significant advancements in treatment over the last two decades, many patients continue to suffer - our mission is to fundamentally change outcomes for these patients.We are seeking an exceptionally...
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Clinical Regulatory Specialist
3 weeks ago
South Plainfield, United States Unicon Pharma Full timeCompany:Unicon Pharma Inc.Location:51 Cragwood Road, Suite 101, South Plainfield, NJ 07080 and various unanticipated locations throughout the U.SPosition Title:Clinical Regulatory Specialist (UPI02)Job Description:Perform the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper) using tools such as Veeva Vault and...
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DEA Compliance Manager
4 weeks ago
Edison, NJ, United States Joulé Full timeJob Title: Controlled Substances Compliance Manager Do not wait to apply after reading this description a high application volume is expected for this opportunity. Location: South Brunswick, NJ Salary: $120k - DH We are seeking a Controlled Substances Compliance Manager (DEA / SOMS) to join a fantastic team! Job Responsibilities: Receiving & Shipping:...
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Manager, Regulatory Affairs
2 weeks ago
Newark, NJ, United States Alvogen Full timeSUMMARY OF POSITION Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: Original 505(b)(2)s, pINDs, INDs, Meeting requests, ANDAs, Amendments, Supplements, Annual Reports, and other life cycle management activities. Works with...
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South Boston, United States AstraZeneca Full timeThis is what you will do: The Manager, Advertising and Promotional Compliance, US serves as the Regulatory Affairs (RA) representative on product promotion review teams. The Manager has responsibility for reviewing and approving the regulatory content of US materials created for product promotion, disease awareness, and public affairs communications. The...
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Medical Data Coder
3 weeks ago
South San Francisco, California, United States Synectics Inc Full time**Job Description:** Medical Data Coder - Regulatory ComplianceWe are seeking a highly skilled Medical Data Coder to join our team at Synectics Inc.**About the Role:As a Medical Data Coder, you will be responsible for accurately coding medical data, including adverse event verbatim descriptions and medication data received from global clinical trials. You...
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International Logistics Compliance Manager
4 days ago
Plainfield, New Jersey, United States Schenker & Co AG Full timeJob Summary: Schenker & Co AG is seeking an International Logistics Compliance Manager to join our team. The ideal candidate will have extensive experience in international logistics, excellent communication skills, and a strong understanding of export regulations.Salary: $70,000 - $90,000 per yearKey Responsibilities:Ensure legal compliance and provide...
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Compliance Analyst
3 weeks ago
South Portland, United States ProSearch Maine Full timeDirect Hire South Portland, Maine Location: South Portland, Maine Type: Direct Hire Job #19796 About the Role: Our client is looking for a meticulous and dedicated Compliance Analyst to join their team, focusing on compliance in affordable housing, specifically within the Low-Income Housing Tax Credit (LIHTC) program. This role involves reviewing...
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Regulatory Affairs Specialist
2 weeks ago
South Pittsburg, Tennessee, United States Colonial Chemical Full timeJob OverviewThis position plays a critical role in ensuring Colonial Chemical's products comply with regulatory requirements.About the RoleThe successful candidate will be responsible for maintaining a thorough knowledge of products, chemistries, and processes to ensure compliance with international regulatory rules and guidance.Main Responsibilities:Liaise...
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Head of Regulatory Affairs
2 weeks ago
Pennington, NJ, United States Scientific Search Full timeHead Regulatory AffairsLocation: RemoteStep into a pivotal leadership role (VP Level) where your expertise in regulatory affairs will shape the future of a transformative biopharma company. My client is on a mission to empower patients battling rare and serious liver diseases. Lead the charge in regulatory strategy for the approval of cutting-edge...
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VP Regulatory Affairs
2 weeks ago
Pennington, NJ, United States Scientific Search Full timeVP, Regulatory AffairsLocation: RemoteStep into a pivotal leadership role (VP Level) where your expertise in regulatory affairs will shape the future of a transformative biopharma company. My client is on a mission to empower patients battling rare and serious liver diseases. Lead the charge in regulatory strategy for the approval of cutting-edge treatments,...