Lead Regulatory Compliance Officer

1 week ago


Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time

We are looking for a highly skilled Lead Regulatory Compliance Officer to join our team at Quanta Consultancy Services Ltd. As a global supplier of sterile injectable pharmaceutical products, we have a robust pipeline of products in development that we will bring to regulated and semi-regulated markets around the world.

Responsibilities
  • The ability to understand HPRA BoH requirements for hosting a market authorisation and act as a Responsible Person for a Market Authorisation filing are essential responsibilities.
  • Effective management and engagement with Global Regulatory colleagues and stakeholders are crucial.
  • Communicating and coordinating vendors/service providers - aligning activities and timelines is vital.
  • BUILDING A QUALITY SYSTEM TO MANAGE THE MA FILING THAT MEETS HPRA REQUIREMENTS IS KEY TO SUCCESS.
  • CAPABLE OF SUPPORTING A WDA FOR RELEASE OF PRODUCT INTO EUROPE.
  • Regulatory Affairs experience in dossier creation and submission in Europe is highly valued.
  • Representing the company as the lead person with all relevant local authorities is an important aspect of this role.
  • Managing Regulatory Affairs activities associated with changes to MAs for all products registered in the territories under your responsibility is a critical task.
  • Directly managing Creation, maintenance and management of MAs current registered details for MAs is also essential.
  • Building relationships and coordinating with product CMO's & wholesale distributor is a key part of this role.

Your Experience:

  • 8-10 years of professional Regulatory Affairs experience in the Pharmaceutical industry.
  • Experience working with the HPRA.
  • Experience reviewing regulatory dossiers.
  • Excellent communication and stakeholder management skills.
  • Experience working with global teams and Regulatory Authorities.


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    About the CompanyWe are a leading Life Science Recruitment agency specializing in pharmaceutical and biotech placements.This opportunity is part of our ongoing effort to provide exceptional service to clients and candidates alike.Key ResponsibilitiesThe selected candidate will be responsible for:Managing event management systems to ensure...


  • Tullamore, Uíbh Fhailí, Ireland Randstad Client Solutions Ireland Full time

    Key RequirementsTo be successful in this role, you will need:A Bachelors degree in Science or related field.At least 2 years experience in a pharmaceutical environment.Strong knowledge of GMP documentation and regulatory compliance.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.What We OfferIn return for...


  • Tullamore, Uíbh Fhailí, Ireland STERIS Canada Corporation Full time

    We are committed to being an Equal Opportunity Employer and strive to attract and retain top talent from diverse backgrounds. Our mission is to create a healthier and safer world through innovative healthcare and life science solutions.Job DescriptionThe Regulatory Compliance Manager is responsible for leading quality improvement initiatives at our AST...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    **About the Role:**Vectura Group plc is looking for a highly skilled Regulatory Affairs Expert for Medical Devices who can play a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. As Person Responsible for Regulatory Compliance (PRRC), you will lead communications and interactions with Competent...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    About the RoleWe're seeking a highly experienced Senior Manager in Regulatory Affairs for Medical Devices to join our team at Vectura Group plc. As a key member of our regulatory team, you will play a critical role in ensuring compliance with European medical device regulations as our Authorized Representative.The ideal candidate will have extensive...


  • Tullamore, Uíbh Fhailí, Ireland STERIS Full time

    About the OpportunityWe are seeking a highly experienced Quality Manager to join our team at STERIS. The successful candidate will be responsible for leading quality improvement efforts at an AST processing or lab facility and ensuring compliance with domestic and international standards.Key ResponsibilitiesImplement and maintain state-of-the-art quality...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    Overview:We're currently recruiting for an exciting opportunity within a Pharmaceutical organization based in Ireland. This position is ideal for professionals seeking to join a leading multinational that excels in its field.Key Responsibilities:Understand and progress change controls using IPI and Veeva Change Control Systems, ensuring adherence to site and...


  • Tullamore, Uíbh Fhailí, Ireland Zoetis EUAFME Full time

    We are looking for a talented and motivated individual to join our team as a Manufacturing Investigator. In this role, you will be responsible for leading investigations and improvement initiatives within manufacturing operations, as well as mentoring others on cGMP expectations.The successful candidate will have a strong understanding of compliance and GXP...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    Job DescriptionWe are seeking a Senior Manager Regulatory Affairs who will assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative.


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    **Job Description:**Vectura Group plc is seeking a highly experienced Senior Manager Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. The...


  • Tullamore, Uíbh Fhailí, Ireland EirGrid plc Full time

    About EirGrid plcEirGrid operates the power system with world-leading levels of variable asynchronous renewable generation, ensuring everyone has power when needed. We are transforming the power system for future generations to enable society to reduce carbon emissions and meet climate change ambitions.Job Description:We seek a Regulatory Revenue Analyst to...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    Job DescriptionVectura Group plc is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative.Principal Accountabilities:•...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    **Responsibilities and Requirements:**We are seeking a highly experienced Medical Device Regulatory Strategist to join our team at Vectura Group plc. As Senior Manager Regulatory Affairs for Medical Devices, you will play a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. You will also...


  • Tullamore, Uíbh Fhailí, Ireland EirGrid plc Full time

    EirGrid plc OverviewWe operate Ireland's electricity grid with world-leading levels of variable asynchronous renewable generation, ensuring that everyone has power when they need it. Our purpose is to transform the power system for future generations, enabling society to reduce carbon emissions and meet climate change ambitions. The Group Regulation Team...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    About the RoleWe are currently recruiting for a QA Associate Specialist to join our team. This is an excellent opportunity for anyone looking to develop their skills and knowledge in a dynamic and challenging environment.Key ResponsibilitiesEnsure the manufacturing of drug products meets the highest standards of quality and regulatory compliance.Develop and...


  • Tullamore, Uíbh Fhailí, Ireland EirGrid plc Full time

    About UsEirGrid plc operates the electricity grid in Ireland, driving innovation and sustainability in the energy sector. We are committed to reducing carbon emissions and meeting climate change and net-zero ambitions through our transformative approach to power system management.Job DescriptionThis Regulatory Revenue Analyst position involves providing...


  • Tullamore, Uíbh Fhailí, Ireland Integra LifeSciences Full time

    Integra LifeSciences is a world leader in medical technology, dedicated to limiting uncertainty for surgeons. We offer innovative solutions in neurosurgery, reconstructive and general surgery, and regenerative wound care. As a Quality Assurance Inspector, you will play a vital role in ensuring the accuracy and compliance of medical devices and components...


  • Tullamore, Uíbh Fhailí, Ireland Steris Canada Corporation Full time

    Steris Canada Corporation is a leading provider of infection prevention solutions. As a Validation and Compliance Expert, you will have the opportunity to work on challenging projects that make a real difference in patient care. Your primary responsibility will be to ensure that our products and services comply with regulatory requirements and industry...


  • Tullamore, Uíbh Fhailí, Ireland Zoetis EUAFME Full time

    The role of Manufacturing Investigator at Zoetis EUAFME involves leading teams in the management of investigations and improvement initiatives within manufacturing operations. The ideal candidate will have a deep understanding of compliance and GXP manufacturing processes, as well as excellent project management capability. Key Responsibilities:Gathering...


  • Tullamore, Uíbh Fhailí, Ireland Randstad Client Solutions Ireland Full time

    About the RoleWe are looking for a skilled Sustainability and Compliance Specialist to join our team in Tullamore. The successful candidate will be responsible for the ongoing development of the EHS management system and its component parts, ensuring regulatory and corporate compliance.