576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients' lives and we need your help.
**This role can be based at either of the following sites: East Hanover, NJ; Libertyville, IL; or Basel, Switzerland**
As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring a foundation of regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset.
Your Responsibilities include but are not limited to:
* Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell and Gene Therapy projects/products. * Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. * Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. * Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. * Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams. * Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions. * Initiate and lead Health Authority interactions and negotiations.