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Reg Affairs Officer

Location: Dublin City Centre, Dublin
Salary: Negotiable
Posted: 2 months ago
Role type: Permanent
Industry: Science, Technology and Operations Practice (STO), Science Leaders & Specialists
Contact name: Maeve Fahey
Contact email: maeve.fahey@hrmrecruit.com

Job description

This speciality pharmaceutical organisation focus on R&D and innovation in the space of women's and men's health. Due to a strong development pipeline for 2020, they are seeking experienced Senior Reg Affairs Officer to join their growing Regulatory team at their Dublin City Centre facility.

The Role

Duties and responsibilities of the Senior Reg Affairs Officers will include:

  • Preparation of submissions including; CMC variation filling, initial MAA filling, labelling updates, renewals, Marketing Authorisation Transfers (MATs), CMC authoring and \ or updates as required
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Prepare and/or review regulatory documentation for DCP, MRP and National applications in line with assigned timelines
  • Actively participate and employ effective communication practices with internal customers
  • Understands the Scope of Work, timelines and deliverables for a given project
  • Prepare status reports and metrics for assigned projects
  • Learn, develop and train

The Person

You will have skills and experience in the following:

  • BSc / Pharmacy degree
  • 2-4 years 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)
  • Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations
  • Experience of EU DCP and MRP MAAs
  • Experience of emerging markets / international RoW markets and regulatory filings
  • Quality control review of technical/ regulatory documents
  • Understanding of Regulatory strategy and determination of documentation requirements

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.

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Maeve Fahey

Science Recruitment Consultant

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