RA Manager

In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
We are seeking highly qualified candidate to fill the position:
Senior Regulatory Project Manager (RACMC) (m/f/x)
The purpose of the Senior Regulatory Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves strategic leadership, efficient resource management, and clear communication with stakeholders and the project team. The Senior Regulatory Project Manager (RACMC) identifies and mitigates risks, maintains high-quality deliverables, and implements process improvements. Resource management is crucial, along with fostering a collaborative team environment. Ultimately, this role ensures RACMC filinges are submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and regulatory compliance.

Lead and coordinate regulatory projects and filings in the field of RACMC
Ensure compliance with all relevant technical and regulatory requirements
Collaborate with internal and external stakeholders to successfully implement regulatory projects, submissions until approval
Create and maintain regulatory project plans, schedules, and resourses
Monitor project progress and report to Global RACMC management
Identify and manage regulatory project risks and issues
Conduct regular project meetings and provide updates to stakeholders
Develop and implement process improvements to enhance project efficiency
Participate or lead assigned non-project tasks and process improvements
Provide technical guidance and support to team members

Master Degree in Regulatory Affairs is a plus
Minimum of 3 years of experience in global regulatory affairs
Project Management knowledge and certification preferred
Proven ability to plan, coordinate and lead projects simultaneously on multiple projects
Experience of working in global environment in interdisciplinary teams
Excellent written and oral communication skills in English, German as a second language preferred
Strong working knowledge of Microsoft Office

Excellent benefits
Work-Life Balance