Manager Regulatory Affairs (m/f/d)

Your tasks:

• Regulatory support of a defined portfolio in the area of medicinal products
• Timely and high-quality preparation of marketing authorization dossiers
• Planning, implementation and coordination of European new marketing authorization procedures
• Strategic planning and implementation of measures to secure existing marketing authorizations within and outside Europe in compliance with the law
• Establishing and maintaining relationships with regulatory authorities and relevant third parties
• Supporting the local market units with regulatory issues
• Participating in projects by contributing regulatory expertise
• Monitoring the regulatory environment and assessing its relevance for the product portfolio

Your profile:

• Structured working style, detail-oriented, team player, problem solver
• High level of precision and strategic thinking
• Very good communication skills
• Very good written and spoken English language skills
• Good IT skills
• Interest in regulatory IT topics