Regulatory Affairs Officer (Pontevedra)

Overview

Asphalion is growing and we are looking for a Scientific & Regulatory Affairs officer to join our CMC unit in pharmaceutical industry. This role works in an international environment and offers opportunities for growth.

Responsibilities

• CMC writing of product‑specific dossiers (Mod. 2/Mod. 3) for new registration applications, variation packages, and renewals mainly in EU and US markets.
• Writing and compilation of product‑specific CMC documentation (mainly Module 3 and relevant Module 2 sections) to support lifecycle activities.
• RA CMC change control evaluation/management when necessary.
• Successful client management of regulatory affairs.
• Responsible for meeting deadlines, ensuring first‑time quality and maintaining customer satisfaction.

Qualifications

• At least 1 year of experience in CMC in Regulatory Affairs in the pharmaceutical industry and/or consultancy.
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