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Senior Consultant, Local Regulatory Affairs – Spain and Portugal REF 1081

We are searching for a Spanish consultant who can join a pharma company with offices in Barcelona, and quickly become and integral part of their team.

Home working and flexibility is offered while we battle the pandemic, but following that, the preference is that the consultant will spend some onsite time each week.

Initially a 6 month contract with the possibility of extension.

Principal responsibilities will include:

  • Acting as the official liaison between the company and the Spanish and Portuguese Health Authorities (the local HAs):
  • Being accountable for regulatory compliance with local legislation at all times
  • Working with regulatory agencies if needed, and manages local health authorities’ meetings if any
  • Regulatory submissions of RMP educational materials etc. as needed by local requirements
  • Submission and approval of clinical trial applications in Spain if required by Global RA team
  • Approval and Local implementation of post-authorization follow-up measures and Risk Management Plans as required
  • Compliance with the Risk Management Plan (in particular for ensuring that the activities for dealing with identified risks approved by the regulatory authorities are implemented)
  • Providing Training on specific regulatory requirements to local affiliate and third parties (e.g. controlled distribution for Soliris; local RMP activities)
  • Providing local regulatory environment intelligence and advice anticipating regulatory hurdles
  • Ensuring that training courses on SOPs, new legal regulations, etc. are carried out
  • Approving all promotional items (incl. training material) and local press releases
  • Ensuring timely implementation of local artwork requirements (i.e. artwork requests and reviews)
  • Contract Type:

    Permanent career opportunity or contract role

  • Location:

    Barcelona, Spain

  • Duration:

    6-12 months

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