Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

(Associate) Director (gn) Regulatory Affairs
 

Your Responsibilities:

  • Assume responsibility for planning and managing all regulatory activities for assigned development program
  • Define global regulatory strategy
  • Develop the regulatory project goals from the overall product development plan
  • Compile and submit IND and clinical trial applications (CTAs) to enable timely start of the clinical trials for the assigned product candidates
  • Organize and drive preparations for meetings and teleconferences with Health Authorities
  • Responsible for developing the target product labelling in close cooperation with, e.g. clinical and commercial functions
  • Provide guidance to other functions to assure clinical trial programs are carried out in accordance with applicable regulations and SOPs
  • Collect, review and analyse Health Authority guidelines, competitor information and regulatory precedents and provide respective advice to the Business Team
  • Provide regulatory risk assessment for development projects

Your Requirements:

  • Scientific degree, preferably with postgraduate degree (e.g. Ph.D.)
  • Minimum 8-10 years working experience in Regulatory Affairs in a (bio)pharmaceutical company
  • Knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals
  • Knowledge of co-development of drugs in conjunction with companion/ in-vitro diagnos-tics is a plus
  • Excellent communication skills, verbal and written (English and preferably German)
  • Ability to organize and carry out diverse activities in a changing environment often under time pressure
  • Strong analytical skills to be able to interpret regulatory data and support critical decisions
  • The ability to work within a team framework and a multicultural environment

Wir bieten Ihnen:

  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse
Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an – auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg