Associate Director IDMP

The Identification of Medicinal Products (IDMP) Business Analyst will play a key role in the management and leadership of the European implementation of the ISO Identification IDMPs standard in our Company. You will be part of a team progressing the strategic project and operational activities in relation with regulatory data submitted to European authorities including IDMP/SPOR (European implementation of ISO IDMP), DADI (replacement of the PDF electronic Application Form) and XEVMPD (Extended Eudra Vigilance Medicinal Product Dictionary or Article 57).

The role also covers several non‑EU related topics.

• XEVMPD
  • Participate in internal activities associated with the use of XEVMPD data in the EMEA.
  • Apply the knowledge of the data requirements and process to the transition to IDMP.
• IDMP
  • Contribute to the development of the IDMP strategy in our Company and work with peers across the Company to explain the strategy and integrate the needs and requirements from partner functions across Regulatory and other parts of the Company.
  • Contribute to the various projects to implement the IDMP strategy in our Company.
  • Work with the Business System Owner and IT counterparts in line with the System Development Life Cycle principles.
  • Contribute to the setup and configuration of the IDMP Maintenance and Submission Tool, ensuring the proper upload of IDMP data into the tool, defining maintenance and submission processes with key stakeholders and supporting the roll‑out of operational activities.
  • Lead the Data Governance body where cross‑functional stakeholders contribute to evolve internal data and systems to converge in line with ISO IDMP and other internal use cases.
  • Contribute to the evolution of the internal Regulatory Data Hub to ensure alignment with ISO IDMP concepts.
  • Ensure synergies with IDMP related topics including XEVMPD and the Digital Application Dataset Integration.
  • Monitor non‑EU IDMP‑related activities.
  • Report to the XEVMPD‑IDMP Team Lead and Senior Management on the progress of the IDMP program and projects.
• External Activities
  • Represent our Company in European Industry Trade Association committees and meeting groups associated with IDMP, taking on leadership roles and representing the industry in meetings and negotiations with health authorities and other stakeholders.

• Bachelor's degree in a science or information technology discipline (required).
• Comprehensive experience in Regulatory Affairs or Regulatory Operations.
• Practical knowledge and experience with ISO IDMP or IDMP/SPOR.
• Good understanding of System Development Life Cycle methodology and the requirements for the validation of information management systems.
• Demonstrated understanding of drug development and execution of regulatory program strategies within the countries and how this impacts regulatory information management strategies.
• Experience as a leader on cross‑functional teams capable of influencing and motivating team members and Senior Management to deliver high‑quality, on‑time project objectives.
• Demonstrated situational leadership and creative problem‑solving within organizations and teams.
• Ability to prioritize own work across several ongoing projects.
• Ability to lead by influence and work effectively in matrix organisational structures.
• Ability to understand details but keep the overall big picture view of projects.

• Accountability
• Adaptability
• Business Processes
• Change Management
• Clinical Trial Agreements (CTA)
• Clinical Trials
• Communication
• Cross‑Cultural Awareness
• Data Management
• Employee Training Programs
• FDA Regulations
• Global Health
• Internal Processes Management
• Process Mentorship
• Pharmacovigilance
• Policy Implementation
• Project Management
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Labeling
• Regulatory Operations
• Regulatory Submissions
• Stakeholder Management

• Program assessment
• FDA Regulations
• Manufacturing & Controls
• Program Evaluation
• Budget forecast
• Research Experience
• Operations Management
• Research & Development
• Strategic Planning
• Contract Management
• Leadership Experience
• Negotiation

Employee Status:
Regular

Flexible Work Arrangements:
Hybrid

Job Posting End Date: 11/10/2025