Project Manager, Regulatory Affairs CMC

Daiichi Sankyo, Inc.; Basking Ridge (NJ); On-site; USD 127,000 - 191,000; Full time

Job summary

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

Qualifications

• 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.

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

Skills

Regulatory project management

Cross-functional collaboration

AI-enabled tools

Global regulatory submissions

Education

Bachelor's Degree Life Science or Pharmacy

Master's Degree preferred

Tools

AI tools (Copilot)

Job description

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.

Job Summary

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 Qualifications

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

Experience Qualifications

• Minimum of 5 years of experience in the pharmaceutical industry required
• Minimum of 3 years of experience in regulatory affairs required
• Project Management knowledge and experience preferred
• Experience in Regulatory Affairs CMC; biologics experience preferred.
• Proven ability to plan, coordinate and lead projects simultaneously on multiple projects preferred
• Proficiency in AI-enabled workplace tools (e.g. Microsoft Copilot)
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization preferred
• Experience of working in global environment in interdisciplinary teams preferred
• Knowledge of project management tools and processes preferred

Travel Requirements

Ability to travel up to 10% of the time. International travel may be required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$127,280.00 - USD$190,920.00

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