Job Description About Daiichi Sankyo Cancer Enterprise
The mission 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, 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 ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological 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 to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA). 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 Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) 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:
- 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.
Qualifications: Education and Experience:
- Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives.
- M.S./PhD. in a scientific discipline 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or PhD. in a scientific discipline with 6-8 years pharmaceutical industry experience and 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
- Advanced knowledge of regulations/guidance documents with strong technical knowledge based upon academic training and job experience.
- Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas.