Senior Manager / Director Of Regulatory Affairs

Overview

Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team. This role focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.

Responsibilities

• Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
• Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
• Working on safety, efficacy and CMC variations : variation typification and documentation preparation.
• Supporting R&D, manufacturing, quality control and quality assurance departments for potential queries.
• Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
• Planning and managing regulatory procedures on behalf of client companies.
• Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
• Managing the authorisation according to national and EU regulations (MRP, DCP and centralized procedures).
• Ensuring all project work aligns with current regulatory guidance and meets internal standards.

Qualifications and Experience

Why working at G&L Scientific?

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