Director of Regulatory Compliance
3 weeks ago
The 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 Reports, 505(b)(2), and 505(b)(1) filings, ensuring they meet applicable regulatory guidelines and the highest quality standards. Additionally, you will critically review documentation intended for submission to the FDA, promoting regulatory excellence and internal consistency.
This is a fantastic opportunity to leverage your experience in regulatory affairs, provide leadership to our team, and drive our organization's success. If you have a strong background in regulatory compliance, excellent communication skills, and a passion for delivering high-quality results, we encourage you to apply.
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Director of Compliance and Regulatory Strategy
4 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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Director of Pharmaceutical Regulatory Compliance
3 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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Regulatory Affairs Director
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob OverviewThe Director, Regulatory Affairs role at TK-CHAIN LLC is a pivotal position that requires an advanced understanding of US regulatory guidelines and federal regulations governing pharmaceutical drug development. As a key member of the team, you will integrate knowledge of these guidelines to ensure compliance in all aspects of our clients' drug...
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Senior Regulatory Compliance Specialist
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob SummaryTk-Chain LLC is seeking a Senior Regulatory Compliance Specialist to lead CMC regulatory affairs initiatives and ensure compliance with US regulatory guidelines.Key ResponsibilitiesIntegrate knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development.Collaborate with functional groups to plan, author,...
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Regulatory Compliance Coordinator
3 weeks 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 Engineer
5 days ago
Princeton, New Jersey, United States Grove Technical Resources, INC Full timeGrove Technical Resources, INC is a dynamic and growing organization, and we are seeking a talented individual to fill the position of CAPA Process Lead. As a key member of our quality team, you will play a critical role in maintaining and improving our quality management system by ensuring effective resolution of quality issues and compliance with...
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Compliance and Regulatory Strategy Lead
3 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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Senior Manager Regulatory Compliance
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeAbout Tk-Chain LLCWe are a leading pharmaceutical company committed to delivering innovative solutions that meet the needs of our customers. Our team is dedicated to ensuring regulatory compliance and excellence in all our submissions to the FDA. We are seeking a seasoned Regulatory Affairs professional to join our team and contribute to our success.The...
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Regulatory Affairs Chemistry Manufacturing
2 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeJob Overview:Lynkx Staffing LLC is seeking a skilled Director Regulatory Affairs Chemistry Manufacturing & Controls to lead global teams in developing and executing regulatory strategies for pharmaceutical companies. As a key member of the organization, you will collaborate with project team representatives to ensure compliance with regulatory requirements...
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Regulatory Affairs Director
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob OverviewTk-Chain LLC seeks a seasoned Regulatory Affairs professional to lead our team in ensuring regulatory compliance and excellence in our submissions to the FDA. As a key member of our organization, you will be responsible for planning, authorizing, compiling, and submitting high-quality regulatory submissions within company timelines and in...
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Strategic Regulatory Compliance Manager
2 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeMain ResponsibilitiesLead Regulatory Affairs Functional Teams (RAFTs) to provide high-quality strategic regulatory input for optimal regulatory outcomes.Develop global/regional regulatory strategies for multiple clinical development projects at all stages.Author and review regulatory documents for submission to US and/or Rest of World regulatory...
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CMC Regulatory Strategy Leader
3 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeJob Description:We are seeking a highly experienced Regulatory Affairs Chemistry Manufacturing & Controls Director to join our client's team. As a key member of the organization, you will be responsible for leading global teams in developing and executing regulatory strategies for pharmaceutical companies.Key Responsibilities:Plan, prepare, and critically...
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Global Regulatory Affairs Strategist
2 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeCompany Overview Lynkx Staffing LLC is a leading recruitment agency for the pharmaceutical industry. Our mission is to provide top talent to our clients and help them achieve their goals.Job Description We are seeking a highly experienced Global Director Regulatory Affairs Strategy to join our team. The ideal candidate will have a strong background in...
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Regulatory Affairs Senior Manager
3 weeks ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob OverviewTK-CHAIN LLC seeks an experienced Regulatory Affairs Senior Manager to lead our regulatory submissions team. Reporting directly to the Director/Associate Director Regulatory Affairs, this role will be based in Pine Brook, New Jersey.In this challenging and dynamic position, you will oversee the planning, authoring, compiling, and submitting...
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Director of Regulatory Excellence
3 days ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeJob Requirements To be successful in this role, you will need:Education and Experience: Ph.D. or PharmD degree5-10 years Regulatory Affairs experienceStrong experience in Regulatory StrategyMust have led or currently leading an NDA or BLA filingMust have led or currently leading the strategy and authoring of a study plan, i.e., pediatric study, etc.Must have...
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Strategic Regulatory Affairs Director
2 days ago
Princeton, New Jersey, United States Taiho Oncology, Inc. Full timeJob DescriptionTaiho Oncology, Inc. is seeking a highly skilled Regulatory Affairs Leader to join our team.As a key member of our regulatory affairs department, you will play a vital role in ensuring the successful development and approval of our oncology products.Responsibilities:Develop and execute global regulatory strategies for clinical development...
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CMC Regulatory Lead
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeRegulatory Affairs LeadWe are seeking a seasoned Regulatory Affairs Lead to oversee CMC regulatory affairs initiatives and ensure compliance with US regulatory guidelines at Tk-Chain LLC.ResponsibilitiesDevelop and implement regulatory strategies to support pharmaceutical drug development.Collaborate with multidisciplinary teams to plan, author, and compile...
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Regulatory Affairs Manager
2 days ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob OverviewThe Sr. Manager, Regulatory Affairs plays a pivotal role in ensuring compliance with US regulatory guidelines and federal regulations governing pharmaceutical drug development at TK-CHAIN LLC.ResponsibilitiesManage all regulatory activities associated with our clients' development projects.Provide regulatory guidance and communicate regulatory...
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Regulatory Labeling Specialist
4 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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Senior Regulatory Content Specialist
3 weeks 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...