GRA Data systems specialist

hace 5 días

Barcelona, Barcelona, España ESTEVE A tiempo completo

Job description:

1. FUNCTIONAL CONTENT

Key Role

Regulatory Data & System Specialist will lead the strategic and operational aspects of regulatory information management within the Global Regulatory Affairs Department in Esteve Headquarters office located in Barcelona. The role implies being up to date with regulatory requirements and future advances in relation to data management, the implementation and adoption of new and existing systems (e.g., RIMS), and ensuring compliance with any Regulatory Agency requirement at Global Level.

Functions

  • Define business processes for appropriate management of regulatory data.
  • Lead initiatives to enhance regulatory information processes and tools, in close cooperation with Tech & Digital.
  • Ensure compliance with Health Authorities' standards regarding regulatory data, particularly for IDMP and related requirements in the EU.
  • Monitor upcoming regulatory changes and ensure adaptation of internal practices to new standards.
  • Develop and maintain relevant regulatory reports, dashboards, and KPIs monitoring.
  • Provide continuous support to RA team (Global and Local) to ensure systems adoption and compliance.
  • Act as subject matter expert in case of audits/inspections.

2. ORGANIZATIONAL CHART & JOB RELATIONSHIPS

  • Line Manager: Head Global Regulatory Affairs
  • Direct Reporting: None
  • External Relationships: Vendors, Regulatory Agencies, Partners

3. JOB PROFILE

  • Required Studies:
  • Bachelor's degree in Life Sciences or related field, with good understanding of IT systems used in regulatory data management such as RIMS and EDMS, or

  • Bachelor's degree in Data Science or similar, with strong knowledge of Regulatory Affairs within Pharmaceutical Industry.

  • Other Specialized Knowledge:

  • Solid understanding of international regulatory requirements and data standards.
  • Knowledge and experience as user in Regulatory Data Management Systems, such as RIMS or EDMS.

  • Expert knowledge on xEVMPD, IDMP, SPOR, PMS, etc.

  • Languages:

  • Fluent level of English is mandatory.

  • Professional Experience:

  • Minimum experience of 7–10 years in the pharmaceutical industry, including strong experience in Global Regulatory Affairs or related roles involving regulatory data management and systems.
  • Previous involvement in the implementation of RIMS/eDMS.
  • Analytical, systematic, and structured mindset, with strong interest in data management.
  • Critical thinking, initiative, and strong interpersonal communication and influencing skills.
  • Change leadership mindset and proactive problem-solving.
  • Ability to manage global projects and adapt priorities.

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