Associate Director Regulatory Affairs(m/w/x)

Beschreibung

You will drive commercial success by managing global marketing authorizations and regulatory strategies, ensuring products remain compliant while leading vital authority interactions.

Anforderungen

• •Seven years pharmaceutical industry experience
• •Five years Regulatory Affairs experience
• •Knowledge of EU regulatory framework
• •Regulatory Life Cycle Management expertise
• •Profound knowledge of EU CTR 536/2014
• •Profound experience with CTIS
• •Good self-management
• •Strong sense of responsibility
• •Attention to details
• •Ability to connect with partners
• •University degree on Science
• •Business fluent English
• •Fluent German or EU language beneficial

Aufgaben

• •Manage marketing authorizations across EU, UK, US, and JP markets
• •Oversee regulatory affairs management for license partners
• •Manage CTD submissions including variations, extensions, and renewals
• •Provide strong support for clinical development initiatives
• •Lead regulatory interactions and documentation for health authorities
• •Establish and implement regulatory strategies aligned with company goals
• •Maintain IB, PBRER, DSUR, CCDS, and related documents
• •Manage and update standard operating procedures

Tools & Technologien

Benefits