Project Manager Regulatory Affairs Operations (gn)

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 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!

Responsibilities:

The regulatory Project Manager belongs to the regulatory operation group within the global regulatory organization.
 
The regulatory project manager works hand in hand with the regulatory strategist and is responsible and accountable for planning, managing, tracking and on time production of regulatory deliverables, with a focus on Europe and USA.
 
The function requires a candidate with highly collaborative skills to work cross-functionally within Morphosys and externally with partners and/or contract organisation. This position support the regulatory lead with regard to regulatory operation activities.  
 
Key responsibilities include:
  • Represents Regulatory Operations on project teams, driving timelines and deliverables related to submission documents. Communicate process, timelines, and document standards to stakeholders. Lead project management activities related to the preparation and tracking of regulatory documents/submissions.  Initiate review/adjudication, QC cycle and approval for the regulatory relevant documents.
  • Point of contact re. timelines and status of submissions / approvals globally. Track progress and review project(s) tasks to meet deadlines appropriately.
  • Coordinate Regulatory Sub Team (RST) as project manager; agenda, minutes, follow up of activities. Support the coordination of the regulatory budget for the assigned product.
  • Contribute to setting up regulatory procedures and best working practices and ensure that these processes are adhered to.
  • Ensure databases for the archival of all regulatory information and documentation are to date.
  • Monitor and track on an on-going basis key regulatory affairs metrics and compliance indicators globally.
  • Supports GxP inspection or due diligence with regard to regulatory systems and regulatory documentation, when applicable.
  • Oversee dispatch of dossiers in liaison with other regulatory and/or other functions.

Requirements:

  • Good understanding of drug development requirements and activities involving Nonclinical, Clinical, CMC, Regulatory Affairs, and Commercial aspects.
  • Experience in Project Management in biological and/or drug development and in the management of cross functional (development) teams.
  • Experience in regulatory operations.
  • Proven people skills
  • Strong organizational skills, work independently, self-motivated and proactive
  • Proactive Team player with strong interpersonal and leadership skills, especially regarding indirect people leadership in a matrix organization. Ability to influence without authority.
  • Excellent organizational skills including knowledge of project management tools.
  • Excellent communication and presentation skills.
  • Goal-oriented and pragmatic approach to work.

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 neccessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg