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Associate Director Regulatory Affairs CMC

Employer
Daiichi Sankyo
Location
Basking Ridge, NJ, United States
Start date
Dec 5, 2020

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country

Job Details

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.
  • Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives.
Qualifications:
Education and Experience:
  • 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
Competencies:
  • 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.

Job Title
Associate Director Regulatory Affairs CMC

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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