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