Description

Lead the European rollout of the ISO Identification of Medicinal Products (IDMP) standard and manage regulatory data submissions to European authorities.

Responsibilities

• Formulate and implement the IDMP strategy by collaborating with cross-functional partner functions across Regulatory and other business sections.
• Coordinate with Business System Owners and IT counterparts using System Development Life Cycle principles to support IDMP Maintenance and Submission Tool configuration.
• Lead the Data Governance committee to enhance internal data and systems in alignment with ISO IDMP and internal use cases.
• Oversee the development of the internal Regulatory Data Hub to ensure alignment with IDMP concepts.
• Manage the transition from XEVMPD to IDMP from both strategic and tactical viewpoints.

Required Skills

• 10+ years of experience in Regulatory Affairs or Regulatory Operations.
• Hands-on experience with Veeva RIM and IDMP/SPOR implementation.
• Deep understanding of ISO IDMP, DA D I, and XEVMPD (Article 57).
• Proven knowledge of drug development and regulatory program strategies.
• Strong grasp of System Development Life Cycle (SDLC) and information management system validation.
• Experience leading cross-functional teams within matrix organizational frameworks.
• Ability to manage multiple ongoing projects and prioritize complex responsibilities.

Preferred Skills

• Experience representing the company in European Industry Trade Association committees.
• Negotiation experience with health authorities.

Key Skills

Education

Bachelor's degree