Sr. Scientist/Associate Director, RACMC Pharm Tech in Basking Ridge, NJ at DSI

Date Posted: 4/16/2021

Job Snapshot

Job Description

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 15,000 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.

Job Summary:

This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team, and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple developmental and post marketing projects, including third party developments. This position develops submission strategy with supervision, prepares content templates and leads technical teams in preparation of late stage and complex submission (e.g., IND, IB, NDA/BLA, Amendments, Supplements, Briefing Books). This position authors regulatory documents where necessary. This position conducts regulatory risk assessment and recommends developmental options. This position acts as the company liaison with the Health Authority (e.g., US FDA and Health Canada) for assigned projects on CMC matters from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members, the Contract Sales Organization (CSO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position requires medium level of supervision and makes decisions with consultation.

  • Planning for Development and Post Marketing Projects: Manages multiple CMC development and post marketing projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.
  • Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.
  • Health Authority Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager.
  • Regulatory Knowledge: Demonstrates sound knowledge of US/Canada/ICH regulatory guidances. Serves as RA CMC representative supporting company initiatives.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • M.S. in a scientific discipline 8-12 years pharmaceutical industry experience with a minimal of 4+ years direct or related CMC regulatory experience, or PhD. in a scientific discipline with 6-10 years pharmaceutical industry experience and a minimal of 4+ years direct or related CMC regulatory experience.
  • Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA.
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.