Execution Hub Associate – Regulatory Support

About the role

The Execution Hub Associate provides regulatory support to international country and cluster regulatory teams, managing the full lifecycle of product registrations, from initial applications through ongoing maintenance to eventual withdrawal.

Key responsibilities

• Prepare and coordinate local M1 dossier components and author submission‑ready documents.
• Identify regulatory requirements for assigned submissions and ensure compliance.
• Perform quality review and approval of dossier tables of contents provided by Hub Submission/Dossier Managers.
• Support cross‑functional activities such as tenders, out‑of‑stock reporting, Annual Product Quality Review, risk‑minimisation plans and launch‑planning regulatory inputs.
• Collaborate closely with Country Regulatory Strategists and Hub Submission Managers to deliver timely, high‑quality submissions.
• Escalate quality, compliance or emerging risk issues identified during dossier management.

Required profile

• Experience in regulatory support or regulatory affairs within the pharmaceutical sector.
• Ability to manage end‑to‑end regulatory dossiers across multiple regions.
• Strong understanding of regulatory requirements and documentation standards.
• Proven capability to work with cross‑functional teams and external partners.

Required skills