Global Regulatory Affairs CMC Project Manager

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Daiichi Sankyo, Inc. in New Jersey, is seeking a Project Manager for Regulatory Affairs CMC to lead global dossier activities, manage schedules, resources, and risk mitigation across development and commercial products.

The role emphasizes collaboration across functions, adoption of AI-enabled tools, and ensuring on-time filings in compliance with regulatory standards; travel up to 10% may be required.

Qualifications

• Bachelors or Masters in Life Science or Pharmacy required; advanced degree preferred.
• Experience in Regulatory Affairs CMC; biologics experience preferred.
• Minimum 5 years in the pharmaceutical industry and 3 years in regulatory affairs.
• Familiar with AI-enabled workplace tools (e.g., Microsoft Copilot).
• Ability to plan, coordinate and lead multiple projects in a global setting.

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 and submissions until approval.
• Monitor submission progress and report project 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
• Travel up to 10%; international travel may be required.

Skills

Project management

AI tools

Cross-functional work

Intercultural skills

Education

Bachelor's or Master's in Life Science/Pharmacy

Tools

Microsoft Copilot

Job description

Daiichi Sankyo, Inc. in New Jersey, is seeking a Project Manager for Regulatory Affairs CMC to lead global dossier activities, manage schedules, resources, and risk mitigation across development and commercial products.

The role emphasizes collaboration across functions, adoption of AI-enabled tools, and ensuring on-time filings in compliance with regulatory standards; travel up to 10% may be required.