Senior Scientist/Associate Director, RACMC

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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

Provide regulatory guidance and strategy to Integrated Project Teams (IPT's) and other functional teams leading to sound scientific development programs and successful registration for new compounds and new indications. Represent Sankyo during FDA interactions; able to schedule and lead meetings with FDA and prepare company personnel for FDA interactions. Determine the content for regulatory submissions as well as evaluate submissions for accuracy. Prepare regulatory responses to requests from health authorities. Direct preparation of annual reports for both marketed and developmental products.

Responsibilities

• Organize and manage the preparation (content and format) of all types of submissions to FDA. Coordinates activities required for timely and accurate reporting of information to existing submissions.
• Facilitate and support liaison activities with functional groups within Daiichi Sankyo Pharma Development and Corporate partners related to assigned products/project areas.
• Provide regulatory support and guidance and manage regulatory submissions
• Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations. Promotes global RACMC services to CMC Operations, Pharmaceutical Development, and Clinical Supplies' Operations within the organization.
• Supervise the identification and compilation of required documentation for submission. Prioritizes workload.
• Evaluate content and adequacy of submissions and identify deficiencies.

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 Life Science Degree required
• Master's Degree preferred
• PharmD preferred

Experience Qualifications

• 10 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields preferred
• Experience in international Regulatory Affairs- CMC 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.