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. […]