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Reg Affairs Officer

Location: Dublin City Centre, Dublin
Salary: Negotiable
Posted: 5 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 Reg Affairs Officer and a Senior Reg Affairs Officer to join their growing Regulatory team at their Dublin City Centre facility.

The Role

Duties and responsibilities of the 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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