Beschreibung

As a Regulatory Affairs Specialist Intern, you will engage in various tasks, including preparing essential documents for marketing applications, managing regulatory databases, and supporting vendor agreements. This role is pivotal in ensuring compliance and facilitating smooth product lifecycle management.

Anforderungen

• •Relevant diploma or degree in health sciences
• •Fluent command of spoken and written English
• •Basic knowledge of international standards in drug development or registration
• •Knowledge in MS Office
• •Positive attitude, initiative, and proactivity
• •Ability to work independently
• •Decisiveness
• •Teamwork skills
• •Adaptability and flexibility
• •Willingness to learn

Aufgaben

• •Administer and coordinate logistical aspects of product lifecycle management
• •Prepare Module 1 documents for new marketing authorization applications
• •Create electronic documents for New Marketing Authorization Applications
• •Prepare documents for administrative, quality, and safety variations
• •Handle renewals for marketing authorization applications
• •Utilize online platforms like Hermes, Yoda, and Confluence
• •Update global regulatory databases
• •Submit CPP requests to EMA
• •Manage invoices, regulatory fees, and purchase orders
• •Assist in preparing contracts and agreements with vendors
• •Support the shipment of documents, CDs, and samples
• •Assist with regulatory affairs labeling activities
• •Conduct literature searches
• •Receive training on requested SOPs and IT systems

Tools & Technologien

Benefits