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Senior Regulatory Project Manager
vor 2 Monaten
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are seeking highly qualified candidate to fill the position:
Senior Regulatory Project Manager (RACMC) (m/f/x)
The position:
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 Life Science or Pharmacy; Master Degree in Regulatory Affairs is a plus
- Minimum of 5 years of experience in the pharmaceutical industry
- 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
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
- Experience of working in global environment in interdisciplinary teams
- Experience of working in interdisciplinary teams
- Solution and detail-oriented; well organised and self-motivated
- 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
- Growth and Development
- Health and Wellbeing Support
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