Manager, Regulatory Affairs RPM

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 Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.

• Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.).
• Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.
• Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.
• Support GRL with scheduling regulatory meetings, preparing agenda and tracking action items
• Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.
• Support DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sections.
• Schedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriate.
• Provide support or coordinate other regulatory activities per direction from GRL and regulatory strategists.
• Share RPM best practices and contributed to RPM process improvement
• Keep current with regulatory and scientific regulations, guidelines and initiatives

Education Qualifications (from an accredited college or university)

• Bachelor's degree, preferably in a scientific discipline required
• Advanced degree (e.g., Masters, Pharm.
  
  D., Ph.D.) preferred

Experience Qualifications

• 4 or more years of relevant pharmaceutical experience (education and/or industry)
• 1 or more years of industry experience (within regulatory is preferred)

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$ - USD$

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