Global Regulatory Affairs Project Manager, CMC & Biologics

Daiichi Sankyo, Inc.; Basking Ridge (NJ); Presencial; USD 127.000 - 191.000; Jornada completa

Descripción de la vacante

Daiichi Sankyo, Inc. is seeking a Project Manager (RACMC) to lead and support complex regulatory filings, ensuring compliance with technical and regulatory standards.

The role emphasizes efficient resource management, risk mitigation, and clear communication with stakeholders and project teams. You will coordinate global dossier generation and submissions across development and commercial products, drive process improvements, manage IT tools and knowledge sites, and promote AI and digital tool

Formación

• Minimum of 5 years of experience in the pharmaceutical industry.
• Minimum of 3 years of experience in regulatory affairs.
• Project Management knowledge and experience preferred.
• Experience in Regulatory Affairs CMC; biologics experience preferred.
• Proficiency in AI-enabled workplace tools (e.g. Microsoft Copilot).
• Excellent cross-functional collaboration in a multinational organization.

Responsabilidades

• 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

Conocimientos

Regulatory project management

Cross-functional collaboration

AI-enabled tools

Global regulatory submissions

Educación

Bachelor's Degree Life Science or Pharmacy

Master's Degree preferred

Herramientas

AI tools (Copilot)

Descripción del empleo

Daiichi Sankyo, Inc. is seeking a Project Manager (RACMC) to lead and support complex regulatory filings, ensuring compliance with technical and regulatory standards.

The role emphasizes efficient resource management, risk mitigation, and clear communication with stakeholders and project teams. You will coordinate global dossier generation and submissions across development and commercial products, drive process improvements, manage IT tools and knowledge sites, and promote AI and digital tool