Regulatory Compliance Engineer
1 week ago
We are currently seeking an experienced Regulatory Compliance Engineer to join our team at TK-CHAIN LLC. In this role, you will be responsible for ensuring that our software applications meet or exceed regulatory requirements. This includes developing releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards. You will also author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment, and utilities equipment.
As a Regulatory Compliance Engineer, you will have a strong background in engineering and experience in regulated industries. You will possess excellent written and verbal communication skills, as well as strong interpersonal skills and the ability to work effectively in a fast-paced multitasking environment. We estimate the salary for this position to be around $125,000 - $155,000 per year, depending on experience.
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Regulatory Compliance Coordinator
7 days ago
Princeton, New Jersey, United States MSCCN Full timeMSCCN is seeking a Regulatory Compliance Coordinator to join our team in Princeton, NJ. This role offers a competitive salary range of $40.00 to $45.30 per hour.As a Regulatory Compliance Coordinator at MSCCN, you will be responsible for ensuring that all documents and records are maintained in accordance with FDA regulations and ISO standards. Your duties...
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Regulatory Compliance Professional
1 week ago
Princeton, New Jersey, United States MSCCN Full timeJob Description: We are seeking a skilled Regulatory Compliance Professional to join our team at MSCCN in Princeton, New Jersey. This role is responsible for managing quality system document control and training activities within regulatory standards.About the Job: The successful candidate will be responsible for managing quality system document control...
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Director of Regulatory Compliance
1 week ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob ResponsibilitiesThe successful candidate for the Director of Regulatory Compliance role will be responsible for overseeing the management of regulatory activities associated with planning, authoring, compiling, and submitting high-quality regulatory submissions to the FDA. This includes preparing and compiling new ANDAs, Amendments, Supplements, Annual...
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Regulatory Compliance Coordinator
1 week ago
Princeton, New Jersey, United States MSCCN Full timeCompensation and BenefitsWe offer a competitive salary range of $32.56 - $45.48 per hour, depending on experience, as well as a comprehensive benefits package, including health insurance, an incentive and recognition program, and 401K contribution.Why Work with Us?Opportunity to work with a leading medical device company in the Princeton, NJ area.Competitive...
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Director of Compliance and Regulatory Strategy
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeAbout TK-CHAIN LLCWe are seeking a highly skilled Director, Regulatory Affairs to join our team at TK-CHAIN LLC. This individual will be responsible for integrating knowledge of pharmaceutical drug development into all aspects of our company's drug development policies and procedures.The annual salary for this position is approximately $195,000, based on...
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Compliance and Regulatory Strategy Lead
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeTK-CHAIN LLC is a dynamic and innovative company that is looking for a highly skilled Compliance and Regulatory Strategy Lead to join our team in Pine Brook, New Jersey.The estimated salary for this role is $140,000 - $200,000 per year, based on industry standards and the candidate's qualifications.Job DescriptionWe are seeking a seasoned regulatory...
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Director of Pharmaceutical Regulatory Compliance
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeAre you an experienced regulatory professional looking for a challenging role in the pharmaceutical industry? Look no further! TK-CHAIN LLC is seeking a highly skilled Director of Pharmaceutical Regulatory Compliance to join our team in Pine Brook, New Jersey.The estimated salary for this role is $130,000 - $190,000 per year, based on industry standards and...
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Documentation Specialist
2 weeks ago
Princeton, New Jersey, United States MSCCN Full timeAbout the Role: We are seeking a skilled Documentation Specialist to join our team at MSCCN in Princeton, New Jersey. As a key member of our quality team, you will be responsible for managing quality system document control activities and ensuring compliance with FDA, ISO, and international regulations.
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Regulatory Labeling Specialist
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob Title: Associate II Regulatory LabelingThe TK-CHAIN LLC is seeking a highly motivated and detail-oriented individual to join our team as an Associate II Regulatory Labeling. This role plays a critical part in ensuring the accuracy and compliance of our pharmaceutical products' labeling submissions to the FDA.About the Role:In this position, you will be...
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Head of US Regulatory Strategy
1 week ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeTK-CHAIN LLC is seeking an experienced Head of US Regulatory Strategy to join our team in Pine Brook, New Jersey. This role requires a minimum of 12 years of pharmaceutical industry experience, with at least 10 years in Regulatory Affairs and 6 years of managerial experience.You will be responsible for leading cross-functional teams to develop and implement...
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Senior Regulatory Content Specialist
1 week ago
Princeton, New Jersey, United States UroGen Full timeJob Title:Senior Regulatory Content SpecialistOverviewWe are seeking a Senior Regulatory Content Specialist to provide strategic leadership and subject matter expertise in the development of clinical regulatory documents. The ideal candidate will have a strong background in medical writing, regulatory affairs, and experience working with cross-functional...
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Princeton, New Jersey, United States TK-CHAIN LLC Full timeAbout Us:TK-CHAIN LLC is a pioneering pharmaceutical company committed to delivering innovative solutions that meet the evolving needs of patients and healthcare professionals. As a Senior Manager, Regulatory Affairs, you will play a vital role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.">Job Summary:We are...
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Chief Regulatory Affairs Strategist
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob OverviewThe Chief Regulatory Affairs Strategist plays a pivotal role in TK-CHAIN LLC drug development programs, ensuring compliance with US regulatory guidelines and federal regulations.This position is responsible for integrating knowledge of pharmaceutical drug development into all aspects of the company's drug development policies and procedures,...
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Associate Regulatory Affairs Professional
2 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeAbout the JobWe are seeking an experienced Regulatory Labeling Associate to join our team at TK-CHAIN LLC. The successful candidate will be responsible for preparing, reviewing, and submitting high-quality regulatory labeling submissions to the FDA.This is a dynamic role that requires strong analytical and problem-solving skills, as well as excellent...
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Senior Regulatory Specialist
1 week ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeCompany OverviewTK-CHAIN LLC is a leading provider of innovative solutions in the pharmaceutical industry. We are committed to excellence and innovation, and we seek individuals who share our passion and values.About the JobThe Senior Associate Regulatory Operations CMC will play a critical role in ensuring the quality and compliance of our regulatory...
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Labeling and Compliance Coordinator
1 week ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeTITLE: Associate, Regulatory LabelingJOB SUMMARYThe Associate, Regulatory Labeling plays a critical role in ensuring compliance with FDA regulations and guidelines.This position involves preparing, reviewing, and submitting regulatory labeling submissions to the FDA, as well as providing guidance and support to internal and external customers.The ideal...
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Pharmaceutical Regulatory Affairs Expert
4 weeks ago
Princeton, New Jersey, United States Gardner Resources Consulting, LLC Full timeGardner Resources Consulting, LLC is seeking a skilled Pharmaceutical Regulatory Affairs Expert to join our team. As a regulatory affairs expert, you will play a key role in ensuring compliance with US pharmaceutical industry and healthcare landscape guidelines.Estimated Salary: $120,000 per yearAbout the Job:This position requires a thorough understanding...
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Senior Medical Writer
4 weeks ago
Princeton, New Jersey, United States Meet Full timeResponsibilitiesDevelop and implement a regulatory document strategy to support our clinical development programsCreate high-quality clinical documents, including protocols, clinical study reports, and investigator brochuresCollaborate with cross-functional teams to ensure document accuracy and complianceManage competing priorities and deadlines to deliver...
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Princeton, New Jersey, United States Diversity Nexus Full timeWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Diversity Nexus.About the RoleIn this key position, you will be responsible for overseeing the quality assurance of software development processes in the pharmaceutical industry. Your expertise will ensure that our products meet global regulatory requirements and exceed...
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Packaging Engineering Specialist
3 weeks ago
Princeton, New Jersey, United States Insight Global Full timeJob DescriptionA 6-Month Contract with a Possible ExtensionInsight Global is seeking a Packaging Technologist in Princeton, NJ. This role involves working on packaging engineering projects to meet corporate sustainability goals and regulatory requirements.The responsibilities include:Collating and formatting specification data for primary, secondary, and...