Regulatory Affairs Specialist

The Regulatory Affairs (RA) Specialist plays a key role in supporting all regulatory functions related to Moleac’s product portfolio. This includes obtaining and maintaining marketing authorizations, managing regulatory activities throughout the product life cycle, and contributing to assigned global projects.

The ideal candidate demonstrates strong interpersonal and communication skills, critical thinking, and a collaborative mindset, with the ability to navigate complex regulatory environments.

Key Responsibilities

• Regulatory Submissions: Prepare, review, and compile high-quality regulatory dossiers for new registrations, variations, and renewals, ensuring scientific accuracy, consistency, and compliance with applicable guidelines and good documentation practices. The role will primarily support Spanish-speaking markets (e.g., LATAM), EU countries, and other assigned market.