Regulatory Affairs Manager

About the role

Sandoz is seeking a Regulatory Affairs Manager to lead its Irish Regulatory Affairs team responsible for global pharmaceutical products. The role ensures timely preparation and submission of registration dossiers, lifecycle maintenance of marketing authorisations, and compliance with EU, HPRA and internal regulations.

Key responsibilities

• Manage the Irish Regulatory Affairs team handling global products across Centralised, MRP/DCP/RUP, and Irish National procedures.
• Oversee preparation and submission of registration dossiers to obtain new Irish Marketing Authorisations.
• Maintain existing Marketing Authorisations, including variations, renewals, PSURs, DSURs, risk‑minimisation measures and other post‑authorisation commitments.
• Develop and execute regulatory filing and product launch strategies in collaboration with regional and local stakeholders.
• Assess CMC data requirements and devise submission strategies aligned with compliance and commercial needs.
• Engage with the HPRA to address application queries and ensure rapid, accurate responses.
• Maintain regulatory databases, systems and department KPIs, and report on performance.
• Conduct gap assessments of internal procedures against regulatory intelligence and update local processes.
• Act as regulatory subject‑matter expert during internal audits and health‑authority inspections.

Required profile

Required skills