Regulatory Affairs & Compliance Specialist

Context

The Pasqual Maragall Foundation was established in 2008 with the mission to promote and conduct excellent biomedical research. The Foundation is deeply committed to making a decisive contribution to global solutions for Alzheimer’s disease and related dementias, as well as to raising public awareness to ensure that scientific efforts addressing these challenges receive the priority they deserve.

Research at the Foundation is carried out at the Barcelonaßeta Brain Research Center (BBRC), a research center established in collaboration with Pompeu Fabra University and "la Caixa" Foundation.

The vision of the Pasqual Maragall Foundation is to achieve “A future without Alzheimer’s”, within a framework of active and healthy aging associated with positive experiences and free from cognitive decline. To this end, the BBRC focuses its research on the primary and secondary prevention of Alzheimer’s disease, made possible through the participation of thousands of volunteers who contribute to scientific studies aimed at significantly reducing the number of people affected in the future.

The Pasqual Maragall Foundation is a private, non-profit organization. Its funding comes from philanthropic donations from organizations and companies, as well as from a network of over 100,000 members who support the Foundation’s research. The scientific staff at the BBRC also secures competitive grants and funding, mainly from European funds and international foundations.

For more information, please visit our websites: www.fpmaragall.org , www.barcelonabeta.org 

The Pasqual Maragall Foundation is a young, consolidated, and growing institution that, together with the BBRC, currently brings together over 250 professionals. The Foundation’s team includes transversal areas such as infrastructure, IT, finance, procurement, human resources, communications, public engagement, and philanthropic fundraising. The BBRC scientific team comprises researchers and professionals from diverse disciplines such as medicine, biology, psychology, and nursing, among others — all within a dynamic environment where continuous challenges are part of everyday work.

About the Position

We are looking for a Regulatory Affairs & Compliance Specialist to design, implement, and lead a high-quality regulatory support service covering all institutional research activities within the Clinical Operations Office of the BBRC.

This role aims to ensure regulatory compliance across all studies, acting as the institutional point of reference for this area and guaranteeing that all activities align with applicable legal, ethical, and quality standards.

The selected professional will lead regulatory and compliance activities, supervise a junior regulatory profile, and work closely with scientific and operational teams to ensure optimal coordination between regulatory, compliance, and clinical operations functions.

Key Responsibilities
Regulatory Strategy and Institutional Support

• Provide expert regulatory advice to internal research teams throughout the entire study lifecycle (feasibility, protocol design, submission, execution, and closure).
• Ensure consistent interpretation and application of European and national regulations across all institutional studies.

Regulatory Documentation and Submissions

• Prepare, review, and coordinate regulatory submissions for observational studies and clinical trials (protocols, IBs, IMPDs, ICFs, DSURs, substantial amendments, notifications, etc.).
• Manage interactions with regulatory authorities (AEMPS, CEIms, EMA, and other competent bodies) on behalf of the institution.

Compliance

• Develop, implement, and maintain regulatory compliance frameworks aligned with European Regulations, GCP, GDPR, and institutional policies.
• Act as the institutional point of contact for compliance matters, deviations, regulatory queries, and documentation requirements.
• Ensure timely implementation of regulatory changes.

Quality, Procedures, and Inspection Readiness

• Contribute to the development and maintenance of SOPs, guidelines, and quality systems related to regulation and GCP.
• Support internal audits, regulatory inspections, and CAPA follow-up.
• Lead inspection-readiness activities across research units.

Monitoring Support

• Support internal monitoring activities when needed, including site compliance verification, review of source documents and essential documents, and data accuracy checks in accordance with GCP.
• Contribute to the harmonization of monitoring practices in line with regulatory and quality requirements.

Training and Institutional Development

• Supervise and mentor a junior regulatory professional.
• Provide internal training to research and operations teams on regulatory requirements, good practices, and regulatory updates.
• Promote harmonization and standardization of regulatory processes across the BBRC.

Qualifications and Experience

• Degree in Life Sciences, Pharmacy, Biotechnology, Biomedicine, or related fields.
• Postgraduate training in Regulatory Affairs or Clinical Trial Monitoring will be considered an asset.
• 3–5 years of experience in Regulatory Affairs within clinical research or the pharmaceutical industry.
• Proven experience in study submissions to AEMPS and Ethics Committees.
• Solid knowledge of European and Spanish clinical trial regulations.
• Familiarity with CTIS, EudraCT, RIMS, and other regulatory platforms.
• Excellent technical writing skills in both Spanish and English.
• Proficiency in digital tools for document and project management.
• Advanced command of Catalan, Spanish, and English is required.

Personal Skills

• Excellent communication and stakeholder management skills.
• Strong attention to detail and accuracy.
• Analytical mindset and problem-solving orientation.
• Ability to work autonomously and collaboratively in multidisciplinary environments.
• Motivation to contribute to a non-profit organization with a high social impact mission.

Position Details

• Start date: Immediate.
• Contract: Permanent.
• Working hours: Full-time (38 hours/week).
• Salary: Based on experience and aligned with BBRC’s compensation policy and Development Plan.
• Benefits: Flexible compensation plan (meal card, health insurance, childcare).
• Holidays: 23 working days per year (pro rata), plus additional days coinciding with long weekends and during March–April and December periods.
• We offer: A highly stimulating work environment with unique infrastructures and professional development opportunities.

Application Process

• Applicants must submit a single PDF file including:
• Motivation letter highlighting interests, experience, and motivation to join the Foundation’s mission.
• Updated CV.
• References: Up to three references may be requested at a later stage of the selection process. All documentation must be sent confidentially by email to talent@barcelonabeta.org , indicating in the subject line: Regulatory Affairs & Compliance Specialist

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