Junior Regulatory CMC Associate

Regulatory CMC Associate (Junior)

📍 Location: Malta

🕘 Full-Time | Pharmaceutical Industry

We are a growing European pharmaceutical company seeking a Regulatory CMC Associate to support our expanding regulatory operations across Europe.

In this role, you will serve as the key liaison between external regulatory consultants and internal departments. You will be responsible for collecting, drafting, and organizing CMC (Chemistry, Manufacturing, and Controls) documentation and contributing to the preparation of high-quality regulatory submissions.

Key Responsibilities

• Coordinate document requests between external consultants and internal stakeholders.
• Draft and maintain technical documents including process flows, manufacturing descriptions, and product specifications.
• Support the preparation of the CMC sections of regulatory dossiers in CTD format.
• Ensure documentation is complete, accurate, and in compliance with applicable regulatory standards.
• Maintain organized regulatory filing systems and version-controlled documents.

Qualifications & Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or related field.
• 2−4 years of experience in Regulatory Affairs, Pharmaceutical Manufacturing, or Quality Assurance.
• Solid understanding of CMC documentation requirements and technical writing.
• Proficiency in English (spoken and written); knowledge of other European languages is a plus.
• Highly organized with strong attention to detail and ability to manage multiple priorities.
• Familiarity with EU regulatory frameworks and CTD structure is preferred.

What We Offer

• A dynamic, collaborative work environment with growth opportunities.
• Flexible work arrangements — remote or hybrid options available.
• Assistance with obtaining EU work permit and residency if required.
• The chance to make a meaningful impact in a mission-driven pharmaceutical company.