5004 Manager, Critical Reagent and Reference Standard Inventory Management
DUTIES:This is a temporary manager level position in the Quality Science and Technology (QSAT) for the centralized program management of reference standards and critical reagents used in the testing of clinical and commercial products.The core function of this role is to establish an integrated inventory management process for reference standard […]
9568 Sr. Project Operations Manager
Responsibilities:Support the Global Regulatory Policy Team in the following regulatory policy activities:Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases.Provide project management support to the policy team in generation of comments on draft guidance’s.Track Team memberships and involvement in policy trade […]
2101 Regulatory Affairs Associate II
Duties:Assists and coordinates Regulatory Affairs nonclinical / clinical activities related to HA interaction and regulatory submissions throughout the product lifecycle.Typically, the Associate II will focus on coordinating submission activities and handling routine submissions. Skills:Agility and Proactivity, including an ability to recognize, understand, articulate and respond promptly to issues, risks and […]
9533 Senior Associate – Regulatory Affairs
Duties:The Company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, […]
9174 Regulatory, Project Manager
Duties:The position requires foundational decision-making, communication and strategic thinking skills. Proficiency in influencing others and working on cross-functional initiatives and a good skill level in strategically navigating and supporting direct reports through change.Project Management support and coordinationAssist in the management of Global Regulatory Team (GRT) and/or GRT sub-team operations, including […]
1871 Regulatory Affairs CMC Manager
Duties:With 7 commercial products and counting, a rich pipeline of mid- to late-stage development candidates and a personal connection to our patients, the Company is the recognized industry leader in rare disease development.This is an exciting time to join the Company and to contribute to the exciting portfolio of products. […]
7077 Regulatory Associate III
Duties:Author sections of BLA on the basis of PTR model documents and available source documentation in discussion and alignment with responsible subject matter experts (SMEs).Authoring includes transfer and formatting of relevant data sections (without modifications) from source documents as well as contextual authoring of written content based on source documentation. […]