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Compliance and Regulatory Specialist
1 day ago
Trenton, New Jersey, United States Biogensys Full timeJob OverviewBiogensys is seeking a Compliance and Regulatory Specialist to join our dynamic team.Position Summary:In this role, you will operate under guidance to provide housing-related support and serve as a conduit between the Housing Division and the Regulatory Services department, facilitating requests for legal insights on behalf of the...
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Senior EHS Compliance Specialist
6 days ago
Trenton, South Carolina, United States Generac Power Systems Full timeAt Generac Power Systems, we are a premier energy technology firm dedicated to fostering a more intelligent world. With over 60 years of innovation in energy solutions, we have transformed the landscape of energy technology.The Senior Environmental Health and Safety (EHS) Specialist plays a pivotal role in overseeing daily environmental, health, and safety...
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Senior Regulatory Affairs Leader
6 days ago
Trenton, New Jersey, United States Atlas Search Full timeAbout the RoleAtlas Search is collaborating with a prominent biopharmaceutical organization in search of a skilled Senior Regulatory Affairs Leader. This position presents a remarkable chance to shape global regulatory frameworks for their cutting-edge pharmaceutical offerings.The annual base salary for this role is positioned between $140,000 and $170,000,...
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Senior Regulatory Strategy Manager
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Trenton, New Jersey, United States Moderna Full timePosition Overview:Moderna Therapeutics is in search of a Senior Regulatory Strategy Manager to join our dynamic team. This pivotal role is designed for an innovative and proactive regulatory professional who can foresee and tackle the complexities associated with securing market authorization for messenger RNA therapeutics, a groundbreaking class of...
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Senior Manager, Regulatory Affairs Strategy
6 days ago
Trenton, New Jersey, United States Moderna Full timePosition Overview:Moderna Therapeutics is on the lookout for a Senior Manager of Regulatory Affairs Strategy to join our dynamic team. This pivotal role is designed for an innovative and adaptable regulatory professional who can foresee and tackle the complexities associated with securing market authorization for cutting-edge messenger RNA therapeutics.Key...
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Trenton, New Jersey, United States SMC Corporation Full timePosition OverviewThe Senior Vice President of Global Quality and Compliance will spearhead and enhance regulatory adherence and quality assurance strategies throughout the organization, ensuring cohesive alignment with corporate quality standards across all global sites. This pivotal role will act as a key collaborator and strategic partner across various...
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Regulatory Affairs Manager
6 days ago
Trenton, New Jersey, United States Stiftung Nv Full timeAre you passionate about fostering relationships across various levels of an organization? If you are a self-driven individual with resilience and the ability to prioritize tasks effectively, we invite you to consider a role as a Regulatory Affairs Manager within our esteemed team.About the RoleAs a key member of our Regulatory Interface and External...
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Regulatory Affairs Manager/Senior Manager
6 days ago
Trenton, New Jersey, United States Gan & Lee Pharmaceuticals Ltd Full timePosition OverviewThis role is pivotal within Gan & Lee Pharmaceuticals Ltd, reporting directly to the Head of Global Regulatory Affairs. The selected candidate will play a crucial role in formulating and executing regulatory strategies, collaborating closely with cross-functional asset teams to prepare, review, and submit regulatory documentation....
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Senior Supplier Quality Specialist
6 days ago
Trenton, New Jersey, United States International Association of Plumbing and Mechanical Officials Full timePosition Overview:The International Association of Plumbing and Mechanical Officials is seeking a Senior Source Quality Engineer. This role is pivotal in ensuring quality assurance leadership in managing Direct and Indirect Suppliers as well as External Manufacturers involved in the production of our products.Key Responsibilities:Deliver comprehensive...
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Compliance Operations Specialist
6 days ago
Trenton, New Jersey, United States BetMGM LLC Full timeAbout UsWe are BetMGM, a leader in transforming sports betting and online gaming across the United States. Our partnership combines the strengths of MGM Resorts International and Entain Group, and our renowned brands include BetMGM Sportsbook, Borgata online, Party Casino, and Party Poker.Our mission is to translate innovative ideas into action, ensuring the...
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Lead Manager for CMC Regulatory Affairs
6 days ago
Trenton, New Jersey, United States Regeneron Pharmaceuticals Full timePosition Overview: The selected candidate will spearhead the regulatory frameworks for biologic and combination products within the designated product portfolio.Key Responsibilities:Oversee CMC/CP product development initiatives, ensuring regulatory compliance during early phases, submissions, and post-market obligations.Engage in cross-functional IOPS...
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Regulatory Affairs Team Leader
6 days ago
Trenton, New Jersey, United States Englewood Lab Full timePosition OverviewAs a Regulatory Affairs Team Leader, you will play a pivotal role in guiding and developing a team of Regulatory Affairs Associates. Your expertise will be essential in navigating complex regulatory landscapes and ensuring compliance across various domains.Key Responsibilities1. **Team Leadership**: Mentor and supervise a dedicated team,...
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Global Trade Compliance Specialist
6 days ago
Trenton, New Jersey, United States MSD Malaysia Full timeGlobal Trade Compliance: Classification Specialist Job OverviewThe Global Trade Compliance (GTC) team plays a crucial role in identifying and implementing trade compliance requirements and processes. This includes executing essential trade compliance functions that are best handled on a global or cross-divisional basis. One of the primary responsibilities of...
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Compliance Analyst
2 weeks ago
Trenton, United States Rockefeller Financial Full timeAbout Rockefeller Capital Management: Rockefeller Capital Management was established in 2018 as a leading independent financial advisory services firm. Originally founded in 1882 as the family office of John D. Rockefeller, the Firm has evolved to offer strategic advice to ultra- and high-net-worth individuals and families, institutions, and corporations...
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Regulatory Officer
1 month ago
Trenton, United States Biogensys Full timeJob DescriptionJob DescriptionWe are hiring a Regulatory Officer for one of our clients in Trenton, NJ.Job Description:Under supervision, perform housing related assistance and act as a liaison between the Division of Housing & Community Resources and the department's Regulatory services in receiving, formulating and transmitting requests for legal...
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Health & Safety Consultant
4 weeks ago
Trenton, United States Compliance Management International Full timeJob DescriptionJob DescriptionCompany SummaryCompliance Management International (CMI) is a premier global provider of environmental, health, and safety (EHS) services, serving clients of all sizes for over 30 years. We collaborate closely with organizations, including Fortune 500 companies and governments, to enhance performance by offering integrated...
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Trenton, United States MSD Malaysia Full timeGlobal Trade Compliance: Classification Specialist Job Description Global Trade Compliance (GTC) is primarily responsible for determining trade compliance requirements and processes, as well as executing select trade compliance functions that are best performed on a global and/or cross-divisional level. Among other centralized trade compliance activities,...
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Senior Geriatric Medicine Specialist
6 days ago
Trenton, New Jersey, United States RWJBarnabas Health Full timeRWJBarnabas Health is actively looking for a dedicated Senior Geriatric Medicine Specialist to become a part of our esteemed medical team.As a prominent healthcare provider in New Jersey, RWJBarnabas Health is seeking a full-time Senior Geriatric Medicine Specialist to enhance our medical group.This role encompasses a comprehensive range of responsibilities,...
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Tax Compliance Specialist
6 days ago
Trenton, New Jersey, United States Verizon Communications Full timeJoin Our Team at VerizonAs a prominent leader in technology and communications, Verizon is dedicated to reshaping global connectivity. We pride ourselves on being a human network that spans the globe, working diligently behind the scenes to foster innovation and collaboration.Your Role and ResponsibilitiesIn this role, you will be responsible for:Ensuring...
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Head of Compliance Audit Oversight
6 days ago
Trenton, New Jersey, United States Mjboyd Full timeJoin Mjboyd as the Head of Compliance Audit OversightThe Head of Compliance Audit Oversight is responsible for leading internal audit initiatives with a focus on regulatory compliance, ensuring alignment with the International Standards set by the Institute of Internal Auditors. Key responsibilities include comprehensive audit planning, evaluating risks,...
Senior Compliance and Regulatory Specialist
1 month ago
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance, and practical application skills. This individual must be a self-starter, results oriented with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS. This role is part of the Clinical Development and Supply division which is part of the broader Pharmaceutical and Consumer Health Segment within the Company’s Pharma Solutions LLC business structure. This role is based out of the Somerset, NJ site. SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required. Facilitate and host customer audits at the Company’s Somerset site to ensure compliance with cGMP’s, as well as Corporate and site standard operating procedures. Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations. Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure. Lead the internal audit program at the site. Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed. Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met. Initiate deviations when site procedures are not followed. Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensure audit readiness. Participate in the preparation of Supplier and Customer Quality Agreements. Participate in global supplier and regulatory meetings and effectively represent the site. Review and approve TrackWise Records as needed acting as a QA Representative. Review and revise departmental SOPs as required. Comply with Environmental, Health & Safety requirements. Other ad hoc duties as assigned. POSITION REQUIREMENTS: Education & Experience: A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function. Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function. Knowledge: Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required. Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required. Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred. TrackWise experience is preferred. ASQ CQA or relevant Certification is highly preferred. #J-18808-Ljbffr
