At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.

Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.

Our headquarters are in Planegg, Germany, and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

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

(Senior) Manager Regulatory Affairs (gn)

Your Responsibilities:

  •  Assume responsibility for planning and managing all regulatory activities for assigned clinical studies or indications
  •  Drives, prepares, compiles and manages Clinical Trial Authorization (CTA) applications (initial and subsequent) and INDs (inclusive maintenance), together with regional regulatory lead
  • Review and provide regulatory strategy related to the documentation pertaining to nonclinical and clinical data prior to submission to HA
  • Ensure adequate interaction with the clinical trial team members and their reporting lines to solve regulatory problems/issues and to advance the project(s) through the clinical development phases. The S/M RA will ensure transparent communication flow to all functions concerned in drug development relevant for his/her scope of duties
  • In collaboration with the Global Regulatory Program head, provide support to scientific advice and orphan medicinal product designation, or health authority meetings as appropriate
  • Develop the regulatory project goals for the assigned clinical studies / indication
  • Support the development of study relevant documents, e.g. study protocol, investigator’s brochure, IMPD, and ensure that they are compliant with regulatory requirements and regulations and the company’s QA (Quality Assurance) guidelines
  • Provide guidance to other functions to assure clinical trial programs are carried out in accordance with applicable regulations and SOPs. Data from these trials should support product registration
  • Keep up to date with regulation and guidance related to clinical trials and registration of medical products in US and Europe and provide respective advice to team
  • Provide regulatory risk assessment for assigned projects / studies and keep management informed of potential regulatory issues
  • Optimize processes within his/her area of responsibility
  • Participate in and contribute to external and internal meetings, conferences and forum, as required

Job Qualifications:

  • Scientific degree, preferably with postgraduate degree (e.g. Ph.D.)
  • Ideally 5+ years working experience in regulatory submissions
  • Knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals
  • Prior experience with managing clinical trials in EU and US
  • 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
  • Simplified application for people from Ukraine (fast track via LinkedIn Profile); additional relocation package

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