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Regulatory Affairs Specialist

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Job Overview:

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Thornshaw Scientific is a leading life sciences agency, and we are seeking an experienced Regulatory Affairs Manager to join our team in Dublin. This is a full-time/hybrid position, reporting to the Global Regulatory Affairs Associate Director.

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Key Responsibilities:

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  • Lead the planning, execution, tracking, and reporting of operational registration and life-cycle management projects for company products.">
  • Promote high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning, and delivery of GRA and Corporate projects.">
  • Maintain a positive approach and attitude in a global multi-stakeholder company to deliver high-quality and timely registrations.">
  • Support corporate growth and patient treatment options.">
  • Line manage more junior team members (internal and external).">
  • Act as responsible manager in the Regulatory Team member for assigned regulatory projects.">
  • Effectively plan, manage, and deliver assigned project workload.">
  • Prepare and be responsible for regulatory submissions, including Marketing Authorization Transfer, CMC variation filing, initial MAA filing, labeling updates, renewals, publishing, CMC authoring, and/or updates as required in line with corporate needs and timelines.">
  • Communicate effectively with Regulatory Authorities and internal functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.">
  • Communicate effectively with external partners on an ad hoc basis.">
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Qualifications and Experience:

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  • Hold a Pharmacy or Scientific Primary and/or advanced Degree(s).">
  • Have >5 years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g., variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).">
  • Be proficient in writing and preparing relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling Experts.">
  • Have experience of EU DCP and MRP MAAs.">
  • Have project management experience.">
  • Have excellent communication skills.">
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About Us:

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Thornshaw Scientific is part of the CPL Group of companies. For further information about this opportunity, please contact Tina at Thornshaw Scientific.