Regulatory Affairs Specialist

Industry: Pharmaceutical
Location: Malta
Basis: Full time
Remuneration: Salary + Benefits

Main Duties:

• Support RIM Vault and other regulatory systems.
• Manage and maintain vendor contracts (NDAs, MSAs, SOWs), ensuring timely completion.
• Keep records up to date in trackers, product folders, and regulatory databases.
• Oversee the artwork review and approval process, coordinating with vendors and regulatory teams.
• Assist with internal audits and external inspections.
• Manage the PMC/Commitments and CAPA process for Global Regulatory Affairs.
• Provide metrics to track compliance, identify gaps, and escalate issues when necessary.
• Handle other regulatory-related tasks as needed.

What skills do you need:

• Prior experience in a regulatory affairs function (1-3 years).
• Scientific degree preferable.
• Fluent in English professionally; other languages advantageous

Eligibility to work in the EU is a must