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.
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).
Bachelor's degree or equivalent work experience is required.
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.)
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 Associated topics: administrative and operational assist, administrative and operational support, administrative assist, administrative support, associate, executive assistant, intern, operator, production, support
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.