Head of Regulatory Affairs Operations (gn)

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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.

Your Responsibilities:

The Head of Regulatory Affairs Operation will lead and oversee all aspects of Regulatory Affairs Operations, with a focus on Europe and USA. 
The primary scope of the Head of Regulatory Affairs Operation role is to design and implement the regulatory operation functions and systems within the Company. 
The person will oversee regulatory affairs solution applications, Regulatory Project Management and Document Management System. 
The Head of Regulatory Operations requires hands‑on involvement with regards to on‑going regulatory submissions while devising strategies so as to establishing, developing and maintaining the regulatory affairs operations function within MorphoSys in coordination with internal and external stakeholders.
 
Key responsibilities include: 
  • Design, implement, and provide continuous improvement of regulatory systems and processes striving for operational regulatory excellence, articulated around the four pillars of Regulatory Project Management, Business Operations, Vendor Management, and Information Management Systems
  • Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to
  • Work closely with internal stakeholders to establish Regulatory Information Management (RIM) systems and databases for the archival of all regulatory information and documentation; monitor and track on an on-going basis key regulatory affairs metrics and compliance indicators globally
  • Regulatory Project Management: lead project management activities related to the preparation and tracking of regulatory documents/submissions
  • Interface with MorphoSys’ IT, QA and R&D departments (i.e. medical writing, CMC, non clinical…) and with external partners (if applicable) on local regulatory system issues management
  • Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide
  • Represent Regulatory Operations on global regulatory subteam and drive timelines and deliverables related to submission documents
  • Build and maintain relationship with internal and external (e.g. DMS, publishing) vendor partners
  • Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation
  • Active participant of the global Regulatory Affairs Leadership Team
  • Provide support, guidance and mentoring to regulatory operation team members

Job Qualifications:

  • Ideally 15+ years of experience in the pharmaceutical industry with several years of experience and broad knowledge in the field of Regulatory Operations, Project Management, Regulatory Information and System Management
  • Experience in defining and implementation of new working standards and related regulatory processes
  • Understanding of regulatory operational landscape, esp. with regard to systems, standards and processes related to clinical trials, regulatory affairs, marketing authorization application
  • Knowledge of electronic document management systems, databases and publishing systems as well as related technologies applicable to regulatory affairs
  • Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment. Ability to analyze problems, identify alternative solutions and implement recommendations for resolution
  • Strong organizational and project management skills. Experience in managing small projects with demonstrated effectiveness working in multidisciplinary teams
  • Excellent written and verbal communication, especially presentation and facilitation skills
  • Good leadership, interpersonal and influencing skills with demonstrated ability to mentor, and develop others
  • Deep project management expertise with demonstrated capability to manage project and budget under short timelines

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. 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