Associate Director, Regulatory Affairs CMC in Bernards, NJ at DSI

Date Posted: 5/16/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

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 Integrated Project Team (IPT) ad hoc member for late stage projects. This position manages multiple assigned developmental and post marketing projects with supervision, including 3rd party developments. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents (e.g., IND, IB, NDA, Amendments, Supplements). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the FDA for assigned projects with support. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops awareness of global requirements through support of global submissions and 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 makes decisions with consultation.

Responsibilities

1. 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 RA CMC project issues.
2. 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.
3. FDA Interactions: Leads FDA interactions with support from higher-level manager.
4. Regulatory Knowledge: Demonstrates expert knowledge of US regulatory guidances. Serves as RA CMC representative supporting company initiatives.

Qualifications

Education and Experience
  • M.S. in a scientific discipline
  • 8-10 years pharmaceutical industry experience with 4+ years direct CMC regulatory experience or PhD. in a scientific discipline with 6-8 years pharmaceutical industry experience and 4+ years direct CMC regulatory experience
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.