Profesores Educación Infantil y Primaria - Dublin

Freelance / Contract - Regulatory Affairs & Quality Assurance Lead Consultant

The Role

ProPharma is currently seeking the support of an independent ‘Freelance / Contract Quality Assurance & Regulatory Affairs Senior Consultant’ for a client based in Madrid. This project is to commence in March 2025 and will run for at least 1 year with 0.4 FTE required (16 hours per week). The role does require Hybrid working (could be 1 day per week or 2 days one week, remote the following) for the duration of the project and you must be able to demonstrate key skills in both QA & RA within the Pharmaceutical industry.

Essential Functions :

• Evaluate the current structure of the Regulatory Affairs and how it interacts with the QMS and QA in general.
• Align the QA approach with the Regulatory Affairs group to ensure a coherent and consistent approach.
• Work across all Regulatory Affairs activities when assessing which improvements can be made (Clinical submissions, CMC etc.).
• Work closely with the Global Regulatory Compliance leader and ensure all changes identified and implemented are working to the necessary standard.
• Use QA techniques to identify and improve any areas of collaboration and correlation between RA & QA.
• Overall support to any other initiatives as and when needed.

Experience required :

• Must be educated to a BSc or higher within a life-sciences discipline.
• Can demonstrate thorough experience in Regulatory Affairs and Quality Assurance.
• Ideally skilled in numerous areas in Regulatory affairs from CTA submissions to CMC (broadness is preferred but not essential).
• Demonstrated experience working in a QA function ideally in a senior or lead function.
• Fluency in English is a must.
• Can perform the position to the requirements set out in the Job description.
• Ideally already based in Spain (Madrid area preferred) or can easily commute and work in Madrid for 2 days biweekly.

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