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, market companies, and health authorities within deadlines.
* Follow up regulatory procedures up to final resolution, reporting on regulatory databases all relevant information and associated documents.
* Inform the organization per internal procedures to ensure implementation of regulatory changes.
* Monitor registration status of products, keep annual schedule of renewals and variations updated with all regulatory procedures to be performed.
* Request implementation of regulatory changes that affect packaging materials and participate in their approval.
* Lead activities carried out for regulatory purposes through consultants, CROs, local agents, and partners.
* Support in preparation and integration of the department’s budget.
* Provide support to market companies for regulatory procedures, planning, and representation in corporate projects.
* Provide regulatory expertise and leadership in cross‑functional projects aligned with business strategy definition.
Qualifications
* Education: Bachelor’s Degree in Life Sciences (advanced degree preferred).
* Experience: Minimum 8–10 years of post‑approval regulatory procedures internationally, especially EU; strong knowledge of CP/DCP/MRP, dossier preparation, regulatory authority interactions.
* Additional: Familiarity with drug development and pre‑approval procedures; hands‑on operational experience managing EU registration procedures.
* Skills: Fluent English; ability to build team relationships and collaborate in a global team environment across stakeholders; effective collaboration with business functions and scientific disciplines.
#J-18808-Ljbffr