YOUR CONTRIBUTION
As Head of Global Regulatory Operations (m/f/d) and member of the Global Regulatory Affairs Leadership Team, you contribute to the development and success of the Merz Therapeutics organization. You lead and develop our Global Regulatory Operations team and be responsible for the management of all activities around the technical creation, filing and reporting of regulatory submissions. In this role, you act globally and work cross-functionally. Your main responsibilities include the following activities:
- Leading the Regulatory Operations Team: Motivating and developing team members and creating an inspiring team environment with an open communication culture.
- Monitoring and optimizing data entry and regulatory master data management: Managing data to ensure accurate regulatory reporting.
- Ensuring sufficient planning and execution of electronic submissions: Coordinating internal and external work packages and managing the budget to ensure all submissions are timely and within budget.
- Ensuring IDMP/SPOR requirements are met: Ensuring compliance with all relevant guidelines.
- Process and quality management: Taking responsibility for continuous process improvements and generating ideas for further digitalization project to support regulatory processes within the department while ensuring high quality within the area of responsibility.
