Global Regulatory Data Standards Expert
2 days ago
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 RoleKey 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
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 ApplyIf 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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