Regulatory Project Manager (RACMC) (m/f/x)

Passion for Innovation. Compassion for Patients.

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:

Regulatory Project Manager (RACMC) (m/f/x)

The position:

The purpose of the Regulatory Project Manager (RACMC) function is to 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.

Roles and responsibilities:

• Coordinate global regulatory dossier generation and submission activities as a project manager.    
• Support global project and submission teams with project management expertise.
• Create and maintain regulatory project and submission plans, schedules, and resources.        
• Identify and manage regulatory submission risks and issues.            
• Conduct regular project meetings and provide updates to stakeholders.                
• Collaborate with internal stakeholders to successfully implement regulatory projects, submissions until approval.                        
• Monitor submission progress and report project team and submission status to Global RACMC management.                
• Develop and implement process improvements to enhance project efficiency.    
• Oversee, manage and maintain IT tools, processes and knowledge management sites.    
• Participate assigned non-project tasks and process improvements.                
• Provide technical guidance and support to team members in processes and IT tools.             
                

Professional experience and personal skills:

• Bachelor or Master degree in Life Science or Pharmacy
• Minimum of 5 years of experience in the pharmaceutical industry
• Minimum of 3 years of experience in 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
• Knowledge of project management tools and processes

• 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
• Strong IT knowledge
            

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu