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.
Manager position is responsible for the preparation, coordination and monitoring of regulatory submissions and regulatory intelligence and other projects within their assigned product/therapeutic area. This position provides critical support to the US/global supervisor (therapeutic area head) in the facilitation of regulatory functions as defined in department SOPs. The position provides a broad exposure to both regulatory and business needs within Daiichi Sankyo. The person must be highly organized, attentive to detail and disciplined. Must demonstrate a consistent ability to work under pressure and meet critical deadlines.
Responsible for preparation, coordination and monitoring of regulatory submissions, (IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings).
Represent Regulatory Affairs as a member of Daiichi Sankyo on project teams; proactively solicits regulatory submittals from other internal departments and within Daiichi Sankyo globally.
Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation.
Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions; Coordination and collaboration with other Daiichi Sankyo global teams/functions (EU and Japan and other regions) to support local and global regulatory needs.
Assist in the formulation of regulatory strategies for products/projects.
Provide guidance related to the compilation of global regulatory dossiers in eCTD format and liaise with FDA project manager to resolve any potential issues.
Maintain a high level of expertise through reading and participation at professional seminars, workshops.
Minimum a B.S. preferably in a scientific discipline.
Preferred an advanced degree (Masters, Pharm.D., Ph.D )
With advanced degree a minimum 2-4 years of relevant pharmaceutical experience. With a Bachelor's degree a minimum of 5+ years of relevant pharmaceutical experience. Preferable to have some experience in Regulatory Affairs.
Knowledge of IND, NDA and document management; basic understanding of regulatory's role in the drug development process.
Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable.
Experience with CTD/eCTD preparations preferred.
Job Title Manager Regulatory Liaison
City Basking Ridge
Functional Area Regulatory Affairs Oncology
State New Jersey
* 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.