Global Regulatory Affairs Senior Manager – Summary

The Global Regulatory Affairs Senior Manager leads assigned post‑approval regulatory activities for Almirall’s global legacy products. The role defines regulatory strategies, and ensures timely and compliant submissions in coordination with market companies, partners, consultants, and cross‑functional teams. It ensures accurate product registration status, drives regulatory implementation across the organization, and represents Regulatory Affairs in internal and external meetings.

Responsibilities

• Define strategy, regulatory procedure, and oversight of timelines and requirements for assigned product(s) in lifecycle maintenance for markets, through liaison with local RA managers, consultants, and partners.
• Prepare and/or review variation packages for labelling, administrative, clinical, and non‑clinical changes for assigned product(s) lifecycle maintenance, ensuring delivery to partners, mark...