RA CMC Senior Manager (Cell & Gene Therapy and Biologics)
Location: East Hanover, New Jersey
Internal Number: 344002BR
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.
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 and Biologics 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.