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Senior Regulatory Affairs Officer

Location: Dublin City Centre, Dublin
Salary: Negotiable
Posted: 19 days ago
Role type: Permanent
Contact name: Helena Boyle
Contact email: helena.boyle@hrmrecruit.com

Job description

A leading specialist Pharmaceutical client with global RA, PV, Clinical, and Quality teams based out of Dublin, are expanding their regulatory affairs team and are looking for a new Senior RA Officer to join the business on a permanent basis.

This organisation are going through an exciting period of growth and development, with a strong product portfolio and R&D pipeline, it is an excellent time to join the business and gain experience in and exposure to global markets and innovative, specialist products in important therapeutic areas while working in a very project manager style position.

The Role

Working alongside the RA Manager, some of the Senior Officer's duties will include:

  • Acts as responsible Regulatory Team member for assigned regulatory projects.
  • Preparation of submissions including CMC variation filling, initial MAA filling, labelling updates, renewals, Marketing Authorisation Transfers (MATs), CMC authoring and \ or updates as required.
  • Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
  • Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).
  • Understands the Scope of Work, timelines and deliverables for a given project.
  • Prepare status reports and metrics for assigned projects.
  • Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
  • Learn, develop and train junior colleagues.

The Person

The successful candidate will have:

  • A minimum of a BSc in a Science related discipline and 3+ years RA experience in Human Health.
  • Experience with:
    • Lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).
    • Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
    • EU DCP and MRP MAAs.
    • Emerging markets / international RoW markets and regulatory filings.
    • Quality control review of technical/ regulatory documents.
    • Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices.
    • Publishing: eCTD Office and or NEES - an advantage.
    • Pharmaceutical artwork review and sign-off.
  • Positive can-do attitude in a growing company with an expanding range of therapeutic product range.
  • Good team player with local Dublin based and internationally based colleagues.

Contact Helena Boyle on (01) 6321870 for a confidential discussion.

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Helena Boyle

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