Beschreibung

In this transversal role, you will bridge the gap between manufacturing and global health authorities to ensure life-saving biological drugs reach the market while maintaining strict regulatory compliance.

Anforderungen

• •Desirable technical pharmaceutical CMC experience
• •Preferred 1-5 years direct Regulatory CMC experience
• •Knowledge of global regulations and guidelines
• •Strategic thinking for technical and regulatory issues
• •Initiative, independent thinking, and anticipatory foresight
• •Effective communication to internal and external audiences
• •Ability to make decisions in moving environments
• •Knowledge of Chemical and Biological products
• •Skills for internal data management systems
• •Ph.D, Master in science/health, or equivalent
• •Fluency in German and English language

Aufgaben

• •Assess manufacturing and control procedures for regulatory compliance
• •Evaluate and decide on the regulatory impact of product changes
• •Organize site meetings to manage regulatory activities
• •Participate in global meetings regarding regulatory changes
• •Communicate regulatory timelines and approval statuses to QA functions
• •Provide regulatory expertise for new product introductions and technologies
• •Advise on change management for transfer projects
• •Write submission-ready CMC documents using optimized terminology
• •Support worldwide marketing authorizations and site registrations
• •Collect GMP-related documents from manufacturing sites
• •Coordinate regulatory requests following dossier variations
• •Prepare answers for Health Authority inquiries with site experts
• •Act as the interface between Global Regulatory Affairs and manufacturing
• •Collaborate on standard operating procedures with regulatory context
• •Support continuous improvement of regulatory working processes
• •Prepare for and participate in inspections as a subject matter expert
• •Optimize the use of company software for regulatory management

Tools & Technologien

Benefits