Global Regulatory Data Standards Expert

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Contract: Permanent Full-Time

Closing Date: 05/12/25

We are seeking a Global Regulatory Data Standards Expert to lead the implementation and governance of ISO IDMP standards and ensure ongoing compliance with EMA requirements for structured medicinal product data. This role will also oversee XEVMPD submissions and support the transition to IDMP, playing a critical part in global regulatory data management.

The Role

Key Responsibilities:

IDMP Implementation & Governance

Lead adoption of ISO IDMP standards (ISO 11615, 11616, 11238, 11239, 11240)
Define and maintain data governance frameworks for IDMP compliance
Collaborate with EMA SPOR services (Substance, Product, Organisation, Referential) for alignment
Support the transition from XEVMPD to IDMP and integration with PMS/SMS systems

XEVMPD (Article 57) Compliance

Manage submission and maintenance of product data in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Ensure compliance with Article 57(2) of Regulation (EC) No 726/2004 and EMA guidelines
Validate data quality using EVWEB and controlled vocabularies

Data Quality & Standardization

Oversee data mapping, cleansing, and enrichment for IDMP and XEVMPD
Ensure controlled terminology alignment across regulatory systems
Monitor and resolve data discrepancies impacting pharmacovigilance and regulatory submissions

Regulatory & Cross-Functional Collaboration

Serve as subject matter expert (SME) for IDMP and XEVMPD
Partner with Regulatory Affairs, IT, and Data Governance teams to ensure system readiness and compliance

Requirements

Required Skills & Experience:

Experienced in global regulatory data standards, IDMP, and XEVMPD (Article 57) compliance
Strong understanding of EMA requirements and controlled terminology
Skilled at cross-functional collaboration with Regulatory, IT, and Data Governance teams
Detail-oriented, proactive, and able to influence global data strategies

Why Join G&L?:

This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants.

If you're passionate about regulatory excellence and digital transformation in life sciences, we’d love to hear from you.

How to Apply

If you would be interested in joining the team at G&L Scientific, please send your CV to [email protected] today.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

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