Regulatory Affairs Specialist – Portugal

About the role

Neuraxpharm is seeking a Regulatory Affairs Specialist to support its CNS portfolio in Portugal and Spain. The role focuses on preparing, managing and submitting registration dossiers, as well as maintaining marketing authorisations throughout the product lifecycle.

Key responsibilities

• Prepare, manage and submit documentation required for registration dossiers to Portuguese health authorities.
• Handle quality and labelling variation packages, renewals and other post‑approval activities.
• Compile and submit Marketing Authorization Transfer (MAT) dossiers for Portugal and Brazil.
• Implement dossiers in electronic Common Technical Document (eCTD) format and maintain the Regulatory Information Management (RIM) system.
• Coordinate regulatory activities with Neuraxpharm partners in Brazil and the corporate regulatory team.
• Monitor regulatory changes and ensure timely compliance with applicable guidelines.

Required profile

• Relevant degree in pharmacy, life sciences or a related field.
• Experience in regulatory affairs within the pharmaceutical industry, preferably in CNS products.
• Familiarity with Portuguese (and optionally Spanish) regulatory requirements.
• Ability to work independently and collaborate with cross‑functional teams.

Required skills

• Proficiency with electronic Common Technical Document (eCTD) submissions.
• Experience using Regulatory Information Management (RIM) systems.
• Strong knowledge of dossier preparation, variation management and marketing authorisation maintenance.