Project Manager, Regulatory Affairs CMC

About the role

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient resource management, and clear communication with stakeholders and the project team. The Project Manager 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 filings are submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and regulatory compliance.

Responsibilities

• Coordinate global regulatory dossier generation and submission activities as a project manager.
• Coordinate biologics CMC change control activities and related regulatory submissions across development and commercial products.
• Coordinate regulatory activities across multiple submissions, variations and change control projects
• 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.
• Drive adoption and effective use of AI and digital tools within RACMC processes

Qualifications

Education:

• Bachelor's Degree
• Bachelor or Master's degree in Life Science or Pharmacy required
• Master's Degree preferred