Regulatory Compliance Professional

3 days ago

Cork, Cork, Ireland beBeeSpecialist Full time €60,000 - €80,000
Job Title

Regulatory Affairs Specialist


   We are seeking a skilled Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring that all regulatory requirements are met, and that our products comply with relevant laws and regulations.



Key Responsibilities:
  • Preparation and submission of new Marketing Authorisation applications
  • Maintenance of approved marketing authorisation dossiers including submission of variations, renewals and follow-up measures
  • Preparation of the above submissions in collaboration with other departments and partner companies
  • Preparation of responses to queries from regulatory authorities and partner companies
  • Publishing of regulatory submissions using relevant Manager Software
  • Review and approval of product artworks to ensure compliance with the relevant MA
  • Interactions with management and partner companies and provision of documentation required to support the MA's they have responsibility for
  • Regulatory compliance activities and GMP documentation (specifications, batch records etc.)
  • Maintenance of Wholesale Distribution Authorisation
  • Maintenance of Regulatory forms, logs and databases with up-to-date regulatory information


Requirements:
  • Level 7 or Bachelor's degree required
  • 2+ years experience in a similar role
  • Preferably working knowledge of eCTD manager software
  • Excellent communication and organisation skills due to the high volumes of documentation


Benefits:
  • An attractive compensation package
  • Bonus
  • Healthcare
  • Pension
  • Enhanced annual leave


   Apply now and take your career to the next level

  • Regulatory Analyst

    2 days ago

    Cork, Cork, Ireland Compliance & Risks Full time

    OverviewThe Regulatory Analyst/Specialist will serve as one of the Global Regulatory Compliance team's experts responsible for regulatory research and analysis, writing detailed regulatory summaries and news comments, assisting with research in relation to customer queries, while working as part of an international team. You will be responsible for...

  • Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skills

    2 days ago

    Cork, Cork, Ireland Compliance & Risks Full time

    Job title: Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skillsReports to: Global Regulatory Compliance Team ManagerLocation: Ireland, Home/Office/Hybrid1 Year Fixed Term ContractOverview of RoleThe GRCT is responsible for monitoring global regulatory developments across a wide range of topics, from Product Safety to WEEE, RoHS,...

  • Regulatory Analyst/Specialist With Japanese, Thai Or Vietnamese Language Skills

    17 hours ago

    Cork, Cork, Ireland Compliance & Risks Full time

    Job title: Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skillsReports to: Global Regulatory Compliance Team ManagerLocation: Ireland, Home/Office/Hybrid1 Year Fixed Term ContractOverview of RoleThe GRCT is responsible for monitoring global regulatory developments across a wide range of topics, from Product Safety to WEEE, RoHS,...

  • 15h Left Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skills

    2 days ago

    Cork, Cork, Ireland Compliance & Risks Full time

    Job title: Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skillsReports to: Global Regulatory Compliance Team ManagerLocation: Ireland, Home/Office/Hybrid1 Year Fixed Term ContractOverview of RoleThe GRCT is responsible for monitoring global regulatory developments across a wide range of topics, from Product Safety to WEEE, RoHS,...

  • Regulatory Compliance Specialist

    1 week ago

    Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €95,000

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our organization. This is a permanent role that requires a strong background in either Quality or Regulatory affairs.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with industry standards.Collaborate with cross-functional teams to resolve...

  • Global Regulatory Compliance Strategist

    4 days ago

    Cork, Cork, Ireland beBeeCompliance Full time €90,000 - €120,000

    Regulatory Compliance Leadership OpportunityWe are seeking a seasoned professional to lead our global regulatory compliance program, driving strategic alignment across multiple business units and geographies.Key Responsibilities:Develop and execute a unified compliance strategy, ensuring international standards and certifications are met.Lead cross-border...

  • Regulatory Compliance Specialist

    7 days ago

    Cork, Cork, Ireland beBeeRegulatory Full time €100,000 - €125,000

    Job OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to develop and implement global regulatory strategies, ensuring seamless compliance with regulatory requirements.About the RoleDevelop comprehensive regulatory plans, aligning them with organizational goals.Analyze trends, stakeholder concerns, and regulatory issues, providing...

  • Expert Regulatory Compliance Consultant

    4 hours ago

    Cork, Cork, Ireland beBeeCompliance Full time €76,320 - €99,150

    Regulatory Compliance Specialist RoleThis is a critical position ensuring our medical technologies align with regulatory requirements.The incumbent will be responsible for analyzing regulatory intelligence and developing strategies to guarantee product compliance throughout the lifecycle.Key Responsibilities:Evaluate the regulatory environment to provide...

  • Regulatory Compliance Manager

    5 days ago

    Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €50,000 - €80,000

    Job DescriptionBeckman Coulter Diagnostics is a global leader in diagnostic solutions. We are seeking a Regulatory Affairs Specialist to join our team.The successful candidate will be responsible for ensuring that quality systems aspects, such as CAPA management and global procedure review, are implemented effectively. This includes participation in...

  • Global Regulatory Compliance Program Manager

    4 days ago

    Cork, Cork, Ireland Johnson Controls, Inc. Full time

    Shape the future of compliance in the HVAC and building controls industryJohnson Controls is seeking a seasoned Program Manager to lead ourGlobal Regulatory Compliance Programacross multiple business units and geographies.This strategic role is ideal for a leader with deep expertise in regulatory frameworks, cross-functional collaboration, and program...