Beschreibung

In this role, you will guide cross-functional project teams, ensuring compliance with regulations while managing resources and budgets. Your expertise will be crucial in leading discussions, evaluating device technologies, and supporting regulatory preparations.

Anforderungen

• •Master or PhD in natural science, engineering, pharmaceutical field, or equivalent
• •Minimum 2-4 years of experience in the pharmaceutical industry
• •Ability to work and lead a cross-functional team
• •Proven knowledge in project and program planning and execution
• •Understanding of regulatory guidelines for drug-device combination products
• •Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker
• •Fluency in English, German is beneficial

Aufgaben

• •Represent GDPD in CMC sub-teams
• •Lead device-related discussions and secure project strategy endorsements
• •Act as the single point of contact for device and packaging issues
• •Plan and manage project resources, schedules, and budgets
• •Assess and negotiate internal and external resource needs
• •Establish and maintain a high-quality Design History File
• •Ensure compliance with internal processes and regulations
• •Contribute to improving process and delivery technology approaches
• •Evaluate device technology for different project phases
• •Support internal and external audits on packaging and medical device matters
• •Assist in preparing regulatory dossiers for medical device registration
• •Respond to health authority queries

Benefits