Manager Drug Regulatory Affairs, 80 – 100% (m/f/d)

Iscador AG is a pharmaceutical company that manufactures, scientifically researches, and distributes worldwide preparations for the integrative treatment of cancer. Mistletoe therapy has been a proven component of integrative cancer therapy for decades. Our goal is to further expand the use of our products in oncology. As a supplement to our team, we are looking immediately or by arrangement for a motivated individual as

Manager Drug Regulatory Affairs, 80 – 100% (m/f/d)

Help us bring medicines for integrative oncology to market by taking responsibility for managing approvals through your professionally efficient approach and reporting to the Head of Regulatory Affairs.

Your tasks

• Administration of RA projects
• Monitoring and timely execution of approval activities for already approved products (life-cycle management)
• Independent preparation, creation, and submission of new approvals and indication extensions
• Creating and revising drug information texts (FI/PI/packaging) and database maintenance. Close exchange and contact with Swissmedic and BfArM
• Communication with authorities in German, English, and Spanish
• Communication and project coordination with license partners in English
• Regulatory Intelligence

Your profile

• You have a pharmaceutical or scientific educational background as well as several years of experience in Regulatory Affairs with a focus on pharmaceuticals
• You have a genuine interest in the approval of herbal and anthroposophic medicines
• Experience in the approval of products both in the Swiss and EU markets is an advantage
• With your organizational skills and forward-looking time management, you keep an overview, recognize difficulties, and communicate them early
• Your communicative and service-oriented demeanor as well as your precise and team-oriented working style convince others
• You are proficient in common MS Office programs as well as eCTD management systems and databases (e.g., EMA database)
• You have very good German and English skills in spoken and written form. Spanish skills are an advantage
• You feel at home in an international organization with cross-functional tasks

Do you want to contribute your expertise to our dynamically growing SME and help shape the future? A versatile and varied activity with an exciting all-round view of the company and cross-departmental activities awaits you. In addition to a family atmosphere, we offer you a modern working environment with attractive employment conditions, flat hierarchies, and short communication paths.

Are you ready to take on this task with us? Then we look forward to receiving your application in electronic form.

Note for personnel service providers:

For this position, we only consider direct applications.