Regulatory Compliance Manager

1 month ago


durham, United States Randstad Enterprise Full time

Randstad Enterprises partners with a well-respected Biotechnology company in RTP to hire amazing talent that convert to becoming a full-time employee. We are currently seeking an amazing talent to jump into the Regulatory Compliance space and add immediate value.


Hybrid Role in RTP/Durham

Monday - Friday


The Regulatory Compliance Manager will be someone who can establish and govern a regulatory intelligence program for PO&T. Consisting of research, analyzing, interpreting, communicating and acting on publicly available regulatory information to drive comp0liance, shape future regulations, and outline risks and opportunities to GxP operations. (GxP oversight related to US, EU, JP and ROW regulations including GMP, GLP, GDP and PV)


Position will be working on:

  • Perform and/or oversee surveillance of publicly available regulatory information from global regulatory agencies and industry forums.
  • Develop, implement, and maintain an effective regulatory information database to summarize and analyze new or changing regulatory information and the potential impact.
  • Track information and document generated responses plans, within the database, to ensure appropriate cross functional collaboration and monitor response plans to closure.
  • Identify and assess potential impact of regulatory information on products, programs or regulatory practices.
  • Communicate the intelligence to relevant groups within PO&T in a timely manner via written communication.
  • Maintain up-to-date general knowledge of regulatory guidance’s and regulations to facilitate collection and evaluation of the ongoing regulatory climate.
  • Coordinate reviews of draft legislation/guidance ensuring alignment between all affected functions influencing regulations.


Experience and Education:

  • Bachelor’s Degree (BS) from a four-year college or university with an emphasis in Science/Engineering; or an equivalent combination of education and experience.
  • Minimum ten (10) years’ experience in pharmaceutical/biotech industry.


  • Durham, United States Randstad Enterprise Full time

    Randstad Enterprises partners with a well-respected Biotechnology company in RTP to hire amazing talent that convert to becoming a full-time employee. We are currently seeking an amazing talent to jump into the Regulatory Compliance space and add immediate value. Hybrid Role in RTP/DurhamMonday - FridayThe Regulatory Compliance Manager will be someone who...


  • Durham, North Carolina, United States Randstad Enterprise Full time

    Randstad Enterprises partners with a well-respected Biotechnology company in RTP to hire talented professionals who can excel in the Regulatory Compliance space and add immediate value.Hybrid Role in RTP/DurhamMonday - FridayThe Regulatory Compliance Manager will be responsible for establishing and governing a regulatory intelligence program for PO&T. This...


  • Durham, North Carolina, United States IQVIA, Inc. Full time

    Job OverviewAs a Regulatory and Clinical Trial Manager at IQVIA, Inc., you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources. You will...


  • Durham, North Carolina, United States G.A.S. Global Full time

    Job OpportunityRegulatory Data & Compliance SpecialistJob SummaryThis role supports global pesticide registrations by providing certificates and legalized documents. The ideal candidate will have experience in regulated industries and strong organizational skills.Key ResponsibilitiesCoordinate and manage timely processing of certificates through government...

  • Regulatory Data

    4 months ago


    Durham, United States G.A.S. Global Full time

    Opportunity Details Regulatory Data & Compliance Specialist JOB-10042448 Anticipated Start Date September 16, 2024 Location Research Triangle Park, NC Type of Employment Contract Hire Employer Info Our client, the world’s leading chemical company, operates in chemicals, plastics, performance products, crop protection, and oil...


  • Durham, North Carolina, United States FastMed Full time

    Job Title: Compliance Program ManagerFastMed seeks a highly skilled Compliance Program Manager to administer and refine its strategic compliance programs, policies, and procedures. This role will be responsible for managing compliance incidents, ensuring operational compliance in areas of privacy and healthcare fraud and abuse, and collaborating with the...


  • Durham, North Carolina, United States MedPharm Full time

    Job SummaryWe are seeking a highly experienced Contract and Regulatory Affairs Specialist to join our dynamic legal team at MedPharm in a fast-paced, high-volume CDMO environment. This individual will have a demonstrated history of working within the pharmaceutical, biotechnology, and CRO industries, with a strong background in contract management, clinical...


  • Durham, North Carolina, United States Duke Health Full time

    Job SummaryDuke Health is seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our clinical research team, you will be responsible for ensuring compliance with regulatory requirements and institutional policies. Your expertise will be essential in maintaining accurate and up-to-date documentation, preparing regulatory...


  • Durham, North Carolina, United States Xponance, Inc. Full time

    About XponanceXponance is a distinguished, woman-led, and entirely employee-owned multi-strategy investment firm dedicated to revolutionizing access to alpha for clients and the wider investment community.Our firm specializes in global and non-U.S. equity investment strategies, employing a multi-manager framework that leverages the unique insights and...


  • durham, United States Xponance, Inc. Full time

    About Xponance Xponance is a distinguished, woman-led, and entirely employee-owned multi-strategy investment firm dedicated to revolutionizing access to alpha for clients and the wider investment community. Established in 1996 by Tina Byles Williams with preliminary AUM of $19 billion as of 9/30/24, our firm specializes in global and non-U.S. equity...


  • Durham, United States Xponance, Inc. Full time

    About Xponance Xponance is a distinguished, woman-led, and entirely employee-owned multi-strategy investment firm dedicated to revolutionizing access to alpha for clients and the wider investment community. Established in 1996 by Tina Byles Williams with preliminary AUM of $19 billion as of 9/30/24, our firm specializes in global and non-U.S. equity...


  • durham, United States Xponance, Inc. Full time

    About Xponance Xponance is a distinguished, woman-led, and entirely employee-owned multi-strategy investment firm dedicated to revolutionizing access to alpha for clients and the wider investment community. Established in 1996 by Tina Byles Williams with preliminary AUM of $19 billion as of 9/30/24, our firm specializes in global and non-U.S. equity...


  • Durham, North Carolina, United States AA2IT Full time

    Job Title: Regulatory Data SpecialistJob Summary:We are seeking a highly skilled Regulatory Data Specialist to join our team at AA2IT. The successful candidate will be responsible for supporting global pesticide registrations by providing a range of certificates and legalized documents.Main Responsibilities:Coordinate and manage timely processing of...


  • Durham, United States Duke Health Full time

    Regulatory Coordinator, Senior Work Arrangement: Remote Requisition Number: 247416 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER Date: Jul 3, 2024 School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical...

  • Compliance Auditor

    2 weeks ago


    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.Compliance Auditor 5119 - G1Occupational SummaryConduct health-system wide compliance audits to ensure data integrity,...

  • Compliance Auditor

    3 days ago


    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. Compliance Auditor 5119 - G1 Occupational Summary Conduct health-system wide compliance audits to ensure data integrity,...

  • Compliance Auditor

    2 weeks ago


    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. General Description of the Job Class Conduct health-system wide compliance audits to ensure data integrity, compliance...


  • Durham, North Carolina, United States The Select Group Full time

    Job Title: Senior IT Auditor for SOX ComplianceJob Summary:We are seeking an experienced IT Auditor to join our team as a Senior IT Auditor for SOX Compliance. The ideal candidate will have a strong background in IT general controls and SOX compliance.Key Responsibilities: Review process documentation and lead walkthroughs of key ITGC processes and controls...


  • Durham, North Carolina, United States Asklepios Biopharmaceutical Full time

    Job SummaryThe Director, Regulatory Affairs CMC is responsible for leading the regulatory CMC strategy and coordinating regulatory operations and logistics for all assigned projects. This role will ensure the timely registration of gene therapy product candidates in the US and internationally.Key ResponsibilitiesDevelop and implement comprehensive regulatory...


  • Durham, New Hampshire, United States University System Of New Hampshire Full time

    About the OpportunityThe University System of New Hampshire is seeking a highly qualified Director to lead its Sponsored Programs Accounting, Financial Compliance, and Post-Award Administration team. As a key member of the Research and Economic Engagement Office (REEO), this position plays a critical role in ensuring compliance with federal regulations,...