Current jobs related to Global Regulatory Specialist - Cork, Cork - HERO Recruitment

  • Global CMC Regulatory Specialist

    7 days ago

    Cork, Cork, Ireland TN Ireland Full time

    Key ResponsibilitiesDevelop deep technical knowledge of CMC drug development science(s).Demonstrate knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and product registrations.Assist in the development of regulatory strategy and update strategy based upon global regulatory changes.Provide high-quality and timely...

  • Regulatory Compliance Specialist

    1 week ago

    Cork, Cork, Ireland Westbourne It Global Services Full time

    Welcome to Westbourne It Global Services:We're a leading global provider of innovative solutions, and we're looking for talented professionals like you to help us deliver exceptional results.About the Job:This exciting opportunity as a Qa Specialist offers the chance to work in a dynamic environment where collaboration, innovation, and quality excellence are...

  • Pharmacometrics Regulatory Specialist

    1 week ago

    Cork, Cork, Ireland Eli Lilly and Company Full time

    Job DescriptionWe are seeking a highly skilled Pharmacometrics Regulatory Specialist to join our team in Cork. As a key member of the Global Pharmacokinetics/Pharmacodynamics (PK/PD) Operations Team, you will be responsible for assisting with PKPD regulatory tasks related to the submission of medicines to global regulatory authorities.The ideal candidate...

  • Regulatory CMC Specialist

    2 days ago

    Cork, Cork, Ireland TN Ireland Full time

    Cork CMC Regulatory ScientistWe are seeking an experienced Regulatory CMC Specialist to join our team in Cork, Ireland. As a critical member of our Global Regulatory Area, you will partner with GRA-CMC Regulatory Scientists to manage submission content for drug substances and products.Your responsibilities will include:Preparing and maintaining regulatory...

  • Global Regulatory Associate

    6 days ago

    Cork, Cork, Ireland TN Ireland Full time

    Job Title: Clinical Regulatory AssociateCompany Overview:TN Ireland is a global pharma company dedicated to delivering safe and effective products to patients worldwide.Job Summary:We are seeking a Clinical Regulatory Associate to join our global regulatory team and contribute to the development of our US and Canada regulatory strategies.Key...

  • Global Regulatory Lead

    2 days ago

    Cork, Cork, Ireland CREGG Full time

    C REGG seeks a talented Global Regulatory Lead to join our team in Co. Clare.The ideal candidate will have a strong understanding of global regulatory requirements and be able to develop and implement effective regulatory strategies.This role involves leading the research, analysis, and communication of information pertaining to the appropriate regulatory...

  • Global Regulatory Compliance Manager

    2 days ago

    Cork, Cork, Ireland TN Ireland Full time

    What You Will Be Doing:As a Regulatory Specialist at TN Ireland, you will be responsible for:Championing compliance to applicable global regulations and standardsMaintaining an audit-ready product databaseLiaising with non-compliant suppliersCollaborating with cross-functional teams to assess and manage risksMonitoring the impact of changing regulations on...

  • Regulatory Affairs Document Control Specialist

    7 days ago

    Cork, Cork, Ireland Oxford Global Resources Full time

    Job RequirementsOxford Global Resources is seeking a Regulatory Affairs Document Control Specialist to join our team. The ideal candidate will have a strong background in technical writing and regulatory affairs.The successful candidate will be responsible for collaborating with cross-functional teams to gather and analyze data related to post-audit...

  • Global Regulatory Coordinator

    3 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Role OverviewWe are seeking an experienced Global Regulatory Coordinator to join our dynamic team at Life Science Recruitment. This coordinator will be responsible for ensuring compliance with regulatory standards, managing submissions, and coordinating annual reporting with notified bodies and FDA.This position requires a thorough understanding of medical...

  • Regulatory Affairs Specialist

    2 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Regulatory Affairs Specialist (Remote/Hybrid)Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...

  • Global Regulatory Lead

    4 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Associate Director Global Regulatory AffairsThis is a critical role that requires a strong understanding of regulatory processes and interdependencies among tasks.Key Responsibilities:People Management: Recruit, develop, and retain a diverse workforce; manage workload based on portfolio prioritization.Regulatory Delivery: Align regulatory/labelling strategy...

  • Regulatory Affairs Specialist

    4 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Regulatory Affairs Specialist (Remote/Hybrid)Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...

  • Regulatory Affairs Specialist

    2 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Regulatory Affairs Specialist (Remote/Hybrid)Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual...

  • Global Regulatory Expert

    1 day ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    Eli Lilly And Company is a global healthcare leader that unites caring with discovery to make life better for people around the world.About the RoleThis position plays a critical role in ensuring the quality and compliance of regulatory documents.Main ResponsibilitiesSupport the development and maintenance of regulatory documentsCollaborate with internal...

  • Regulatory Affairs Specialist

    5 days ago

    Cork, Cork, Ireland Stryker Group Full time

    Key Areas of Responsibility:Stryker Group seeks a highly skilled Regulatory Affairs Specialist to assist in the development of local, regional, and global regulatory strategies.Responsibilities include participating in advocacy activities, evaluating the regulatory environment, anticipating regulatory obstacles, and developing solutions. The ideal candidate...

  • Regulatory Compliance Officer

    4 days ago

    Cork, Cork, Ireland PE Global Full time

    About the RolePE Global is seeking a Regulatory Compliance Officer to work on behalf of a leading API company in Cork, Ireland. As a QA Validation Specialist, you will play a key role in ensuring compliance with corporate policies, GMP and regulatory requirements.Key ResponsibilitiesMaintenance of a robust Quality culture through operational...

  • Regulatory Compliance Specialist

    17 minutes ago

    Cork, Cork, Ireland TN Ireland Full time

    We are looking for a highly skilled and experienced Regulatory Compliance Specialist to join our team. In this role, you will be responsible for implementing global regulations and guidance into submission processes and ensuring final document content and structure are aligned with local regulatory requirements.Responsibilities:Implement global regulations...

  • Regulatory Affairs Specialist

    1 week ago

    Cork, Cork, Ireland Eli Lilly and Company Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Eli Lilly and Company. As a key member of our clinical pharmacology department, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the development of new compounds and therapies.Your primary responsibilities will include:Support I...

  • Regulatory Compliance Specialist

    10 hours ago

    Cork, Cork, Ireland Tandem Project Management Limited Full time

    About the RoleWe are seeking a seasoned Regulatory Compliance Specialist to join our team at Tandem Project Management Limited. In this role, you will be responsible for coordinating regulatory requests, managing Annual Product Quality Reviews, and supporting updates to site quality systems.Key responsibilities include:Coordinating Regulatory Requests...

  • Senior Regulatory Specialist

    6 days ago

    Cork, Cork, Ireland Real Full time

    Senior Regulatory Specialist (CR/4004712) Cork, Republic of IrelandSalary: EUR70 - EUR75 per hourWe're looking for a Senior Regulatory Affairs Specialist for a fast-growing med tech company based in Cork (Ireland). The successful candidate will collaborate with cross-functional teams to facilitate regulatory approvals, manage submissions, and maintain...

Global Regulatory Specialist

2 weeks ago

Cork, Cork, Ireland HERO Recruitment Full time

Job Summary:

This is a hybrid role, located in Cork, Ireland. As a Senior Regulatory Affairs Specialist with our client, you will provide strategic, tactical, and operational direction to expedite CMC development of the portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.

  • Oversee the preparation and documentation of specified regulatory submissions.
  • Provide regulatory leadership and direction for products listed as primary responsibilities.
  • Manage submission timelines, monitor approval status, and communicate change status to interested personnel in a timely manner.
  • Have a good understanding of existing and emerging pharmaceutical & biotech-related regulations.
  • Provide the necessary CMC commitment information to site personnel.
  • Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process (review/approval deviations, status of approval of change, etc.).