We have other current jobs related to this field that you can find below

  • Compliance and Regulatory Specialist

    21 hours ago

    Trenton, New Jersey, United States Biogensys Full time

    Job 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...

  • Sr. Manager, Regulatory Operations

    1 week ago

    Trenton, United States Proclinical Staffing Full time

    Sr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...

  • Sr. Manager, Regulatory Operations

    1 week ago

    Trenton, United States Proclinical Staffing Full time

    Sr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...

  • Sr. IT Compliance Analyst

    1 month ago

    Trenton, United States SHI International Full time

    Job Summary The Sr. IT Compliance Analyst will be responsible for managing IT-related audits and examinations with groups internal and external to SHI. The Sr. Analyst will serve as a subject matter expert in the areas of security controls and security risks throughout the organization. The candidate chosen will be a key member of our Compliance Team within...

  • Compliance Operations Specialist

    6 days ago

    Trenton, New Jersey, United States BetMGM LLC Full time

    About 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...

  • Senior EHS Compliance Specialist

    6 days ago

    Trenton, South Carolina, United States Generac Power Systems Full time

    At 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...

  • Regulatory Affairs Team Leader

    5 days ago

    Trenton, New Jersey, United States Englewood Lab Full time

    Position 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,...

  • Global Trade Compliance Specialist

    5 days ago

    Trenton, New Jersey, United States MSD Malaysia Full time

    Global 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...

  • Regulatory Officer

    4 weeks ago

    Trenton, United States Biogensys Full time

    Job 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...

  • Health & Safety Consultant

    4 weeks ago

    Trenton, United States Compliance Management International Full time

    Job 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...

  • Regulatory Affairs Manager

    5 days ago

    Trenton, New Jersey, United States Stiftung Nv Full time

    Are 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...

  • Global Trade Compliance: Classification Specialist

    4 weeks ago

    Trenton, United States MSD Malaysia Full time

    Global 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,...

  • Senior Regulatory Affairs Leader

    6 days ago

    Trenton, New Jersey, United States Atlas Search Full time

    About 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,...

  • Head of Compliance Audit Oversight

    6 days ago

    Trenton, New Jersey, United States Mjboyd Full time

    Join 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 Regulatory Strategy Manager

    5 days ago

    Trenton, New Jersey, United States Moderna Full time

    Position 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...

  • Lead Manager for CMC Regulatory Affairs

    5 days ago

    Trenton, New Jersey, United States Regeneron Pharmaceuticals Full time

    Position 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...

  • Sr. Project Engineer

    1 month ago

    Trenton, United States LVI Associates Full time

    Sr. Project Engineer - Land Development Are you a seasoned Professional Engineer with expertise in stormwater management and land development? We are seeking a Sr. Project Engineer to take the lead on pivotal projects within the heart of New Jersey's civil engineering sphere. This permanent position is an extraordinary opportunity for an individual ready to...

  • Senior Manager, Regulatory Affairs Strategy

    5 days ago

    Trenton, New Jersey, United States Moderna Full time

    Position 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...

  • Regulatory Affairs Manager/Senior Manager

    5 days ago

    Trenton, New Jersey, United States Gan & Lee Pharmaceuticals Ltd Full time

    Position 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....

  • Compliance Manager

    2 months ago

    Trenton, United States North Central Missouri College Full time

    CLASSIFICATION: AMP (salaried) DEPARTMENT: Workforce Development Board REPORTS TO: Executive Director of the Workforce Development Board FLSA STATUS: Exempt FULL TIME/PART TIME: Full-Time, works year round LOCATION: Trenton, Missouri-Main Campus-WDB Building Position Summary: The Compliance Manager is responsible for assisting in the oversight of programs...

Sr Compliance and Regulatory Specialist

1 month ago

Trenton, United States System One Full time

Title:

Sr Compliance and Regulatory Specialist

Location:

Somerset NJ 08873 Onsite daily

Duration:

3 Months - Temp to hire

Shift:

Monday through Friday 8AM-5PM onsite

Education:

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

OR 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

Requirements:

Required understanding of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field

Proficient in FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.

Nice to Have's:

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

Responsibilities:

Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.

Facilitate and host customer audits at the Catalent 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 ensuring audit readiness.

Participates 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.

#J-18808-Ljbffr