Skip to main content

This job has expired

You will need to login before you can apply for a job.

Regulatory Publishing Associate

Employer
Daiichi Sankyo
Location
Basking Ridge, New Jersey, United States
Start date
Jun 19, 2019

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
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 :

The Regulatory Publishing Associate is responsible for the planning, publishing (eCTD, NeES, paper), review and delivery of regulatory submissions to global Health Authorities within required timeframes. The primary accountability for this role is focused on the lifecycle submissions portfolio, but there is additional support for major/complex submissions. The Associate is responsible for the compilation, publishing, and technical quality control / troubleshooting of Regulatory submissions. The individual may also support the implementation of new systems and processes.
Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSURs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.

Responsibilities:
  • Primarily responsible for the planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
  • Liaise with RegAffairs and R&D authoring groups to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards.
  • Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented internally. Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
  • Proactively troubleshoots technical / quality issues related to the preparation and dispatch of submissions
  • Maintain / update database and tracking spreadsheets to ensure the timely and accurate retrieval of information
  • On an ongoing basis actively participate in special projects (e.g., developing processes for electronic submissions, implement use of electronic publishing system for additional types of submissions).
Qualifications:

Education:
  • Bachelor's degree or equivalent work experience is required.
Experience:
  • 3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Lorenz docuBridge, Veeva Vault, ISI Toolbox, etc.)
Competencies:
  • Proficiency in publishing paper, NeES, and eCTD submissions and using related tools.
  • Strong understanding of global regulatory requirements and submission processes including Global Regulatory regulations and guidelines (FDA, EMA, and ICH).
  • Applicable knowledge of the drug development process.
  • Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
  • Ability to balance multiple tasks to meet priorities and timelines
  • Self-starter with superior time management skills, and ability to work independently or in teams
  • Strong attention to detail


Job Title
Regulatory Publishing Associate

City
Basking Ridge

Functional Area
Regulatory Management Operations

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

Twitter

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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert