Senior Regulatory Affairs Specialist – Clinical Trials; CTIS

Are you a Regulatory Affairs professional with solid experience in EU Clinical Trial Regulation (CTR) and submissions via CTIS and AEMPS?

At the Barcelonaßeta Brain Research Center (BBRC) – research center of the Pasqual Maragall Foundation – we are looking for a Senior Regulatory Affairs Specialist to lead institutional clinical trial submissions and ensure full regulatory oversight across our research portfolio focused on Alzheimer’s prevention.

This role sits within the Clinical Operations Office and acts as the institutional reference for regulatory strategy and compliance.

• Lead regulatory strategy for institutional clinical trials under EU CTR.
• Prepare and submit dossiers via CTIS
  , AEMPS
  , and Ethics Committees (CEIm).
• Manage substantial modifications, DSURs, safety notifications, and regulatory updates.
• Act as primary contact with competent authorities and regulatory bodies.

• Ensure compliance with EU CTR, GCP, GDPR
  , and national regulations.
• Support inspection-readiness and regulatory audits.
• Contribute to regulatory risk assessment and mitigation strategies.

• Develop and maintain SOPs related to regulatory activities and GCP.
• Support CAPAs and quality system improvements.
• Promote harmonization of regulatory processes across research units.

• Supervise and mentor a junior regulatory profile.
• Provide internal training on regulatory requirements and updates.
• Collaborate closely with scientific and clinical operations teams.

• Degree in Life Sciences (Pharmacy, Biotechnology, Biomedicine, Biology or related field).
• Minimum 3–5 years of experience in Regulatory Affairs within clinical trials involving Investigational Medicinal Products (IMPs) in a clinical research institution or pharmaceutical industry setting.
• Demonstrated experience in the preparation and submission of clinical trial applications under the EU Clinical Trial Regulation (EU CTR) via CTIS
  .
• Proven experience interacting directly with AEMPS and Research Ethics Committees (CEIm).
• Solid knowledge of ICH-GCP, EU CTR, and Spanish clinical trial regulatory framework
  .
• Experience managing substantial modifications, safety notifications, and Development Safety Update Reports (DSURs).
• Familiarity with Eudra
  
  CT, RIMS, and other regulatory platforms.
• Advanced level of English and Spanish;
  Catalan is an asset.
• Proficiency in digital tools for document management and regulatory tracking.

• Location:
  
  Barcelona
• Contract:
  
  Permanent, full-time (38 hours per week)
• Salary:
  Commensurate with experience and aligned with the institutional compensation policy
• Benefits:
  Flexible benefits scheme including meal vouchers, health insurance and childcare support
• The opportunity to join a leading European research center focused on the prevention of Alzheimer’s disease and related dementias within a scientifically rigorous and collaborative environment.