(Associate) Director (gn) Regulatory Affairs

MorphoSys’ mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

We would like to fill the following vacancy as soon as possible:

(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
  • Lead the preparation and submission of IND and clinical trial applications (CTAs) to enable timely start of the clinical trials for the assigned product candidates
  • Drive and/or support the preparation of line extensions and/or marketing authorisation applications in Europe and USA and other regions, when applicable
  • Organize, drive preparations and conduct meetings and teleconferences with Health Authorities
  • Responsible for developing the target product labelling in close cooperation with, e.g. clinical and safety 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 global Project or Clinical Team
  • Provide regulatory risk assessment for his/her development projects
  • Manage the regulatory activities related to the maintenance and life cycle management of marketed products, when applicable
  • Contribute to the setup of the Quality Management System with regards to regulatory processes

Your Requirements:

  • Scientific degree, preferably with postgraduate degree (e. g. Ph. D., PharmD.)
  • Ideally minimum ten to twelve years working experience in (Global) 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 diagnostics 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

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Thank you for your interest! We are looking forward to receiving your pertinent application docu­ments. For your application please use exclusively our career portal www.morphosys.com/careers/job-opportunities. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg

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Über MorphoSys AG

MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of...
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