Senior Manager (gn) Regulatory Affairs

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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, collaborating 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!

Global Regulatory Affairs is actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation.
 

Your Responsibilities:

The purpose of the regulatory affairs senior manager is to provide support and or manage in the preparation and execution of global regulatory strategies and to manage the submission, approval, and maintenance of applications for clinical trials, marketing applications or other related regulatory submissions.
  • Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
  • Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes
  • Contribute to development and evaluation of regulatory strategies for projects.
  • Review and provide regulatory comments to quality-, safety- and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, orphan designation, annual report, pediatric pans, ODD, DSUR, PIP…)
  • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.

Job Qualifications:

Professional skills & experience
  • Minimum of 5 to 7 years’ industry experience of which at least 4 years’ regulatory experience
  • Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
  • Experience in all phases of drug development
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Experience in IND / CTA requirements
  • Knowledge of international regulatory affairs
  • Experience with maintenance of regulatory authorizations
  • Experience with supporting a project with development activities
  • eCTD experience
Personal skills & competencies
  • Excellent written and spoken communication skills
  • Good interpersonal skills
  • Attention to details
  • Ability to work in teams
  • Awareness of Regulatory Affairs
  • Contribution to Pharma business
  • Good organizational and planning skills

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. 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