Manager Regulatory Affairs (m/w/d)

Your main tasks:

• You are responsible for Regulatory support of a defined portfolio in the area of medicinal products
• You ensure timely and high-quality preparation of marketing authorization dossiers
• You are responsible for Planning, implementation and coordination of marketing authorization applications in Europe
• Strategic planning and implementation of measures to ensure existing marketing authorizations in and outside Europe comply with the law
• Establishing and maintaining relationships with regulatory authorities and relevant third parties
• You are supporting the local market units in terms of regulatory tasks
• You participate in projects by contributing regulatory expertise
• Monitoring the regulatory environment and assessing its relevance for the product portfolio

Your profile:

• You hold a University degree in sciences
• You have at least 3 years of work experience in European and international drug regulatory affairs
• You bring a sound knowledge of pharmaceutical regulations and directives in the EU
• You have the ability to work independently and autonomously
• You are structured working style, detail-oriented, team player, problem solver
• You have a high level of precision and strategic thinking
• You have a very good communication skills
• You are fluent in the English language (written & spoken), German language skills are an advantage
• Good IT skills
• Interest in regulatory IT topics

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