Associate, Regulatory Operations Publishing in Basking Ridge, NJ at DSI

Date Posted: 2/16/2021

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:

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 Reg Affairs 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: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Education/Experience:

Bachelor's Degree or equivalent work experience required

4 or More 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.) preferred

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.