Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary:

The Associate Director, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director 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 Associate Director, RPM is considered an expert for all RPM activities and processes and is responsible for independently leading regulatory project management activities without additional guidance. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities.

Responsibilities:

• Strong understanding and expertise of regulatory and the RPM role and understand key regulatory milestones and strategies.

• Plans, coordinates, and reviews 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.)

• Develops less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions and may be involved with preparation of more complex Module 1 documents if delegated by the USRA strategist

• Works independently, predicts the needs for the GRL and GRT rather than being directed and helps drive coordination of regulatory activities.

• Supports GRL with scheduling regulatory meetings, preparing agenda and tracking action items.

• Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.

• Supports DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in preparation of regulatory sections.

• Schedules rapid response team (RRT) meeting, creates response templates and coordinates processes for authoring and review of health authority response as appropriate.

• Coordinates processes for core BB or FDA BB preparation, creates previous history section, drafts meeting request based on draft BB, and effectively participates in document review.

• Works on additional regulatory activities per direction and strategic input from GRL and regulatory strategists.

• Suggests and integrates operational and procedural excellence best practice into RPM processes and activities to enhance regulatory affairs capabilities.

• Keeps current with regulatory and scientific regulations, guidelines and initiatives

Qualifications:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

• Bachelor's Degree required

• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred

Experience Qualifications:

• 4 or More Years relevant pharmaceutical experience

• 1 or More Years in regulatory Affairs 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.

At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.