Regulatory Affairs Associate

hace 7 días

Barcelona, Barcelona, España Inter Regulatory A tiempo completo

Regulatory Affairs Associate (Medicines)

Location:
Barcelona, Spain (Hybrid – Barcelona Health Hub)

Company:
Inter Regulatory

Employment Type:
Full-time

About the role

Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a
Regulatory Affairs Associate (Medicines)
to join our consultancy based in
Barcelona
, primarily working from the
Barcelona Health Hub
.

This role is suited to a regulatory professional with
3–5 years' experience
in pharmaceutical Regulatory Affairs who has
hands-on experience authoring regulatory dossiers
. The position involves delivering UK, EU, and US regulatory work in a consultancy environment, with a strong focus on
CMC documentation
and
DMF management
.

Key responsibilities

  • Authoring, reviewing, and maintaining pharmaceutical regulatory dossiers for the UK and EU (CTD / eCTD)
  • Managing
    CMC documentation
    for UK and EU regulatory submissions
  • Preparation, maintenance, and lifecycle management of
    Drug Master Files (DMFs)
    , including publication and updates
  • Supporting
    US (FDA) regulatory applications
  • Working closely with internal scientific and quality teams, and with external clients
  • Contributing to the expansion of Inter Regulatory's pharmaceutical consultancy offering across Europe

Required experience and qualifications

  • 3–5 years' experience in
    pharmaceutical Regulatory Affairs
  • Proven experience writing regulatory dossiers
    (essential) (Modules 3 or 4)
  • Strong understanding of
    CMC regulatory requirements
  • Exposure to
    UK, EU, and/or US regulatory pathways
  • Degree (or higher) in a
    scientific discipline
    or closely related field
  • Fluent English and Spanish
    , plus ideally a
    third language

Working model

  • Hybrid role
  • Primarily based at the
    Barcelona Health Hub
  • Part of a growing, distributed European Regulatory Affairs team

Why join Inter Regulatory

This role offers hands-on involvement in real regulatory submissions across multiple jurisdictions, broad technical exposure, and the opportunity to grow with a scaling regulatory consultancy rather than a narrow in-house function. You will be joining a small, internatioanl company operating in the US, UK, EU and China.

Apply via LinkedIn or contact us directly for more information (-)

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