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Regulatory Affairs CMC Director (Biologics) (345707BR)
Job Description 583! 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 a senior member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for complex projects and products covering development, registration and approval/post approval activities.
Your Responsibilities include but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy for Biologics projects/products drawing on extensive regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination,
submission) for assigned projects/products, while applying the global strategy into submissions.
• Identify the required documentation and any content, quality and/or timeliness 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 Health Authority submissions, establishing
and applying CMC global regulatory strategies, current regulatory trends and guidelines.
Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and epublishing
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative
partnerships with stakeholders.
• Initiate and lead Health Authority interactions and negotiations including more complex interactions;
setting objectives, preparing briefing books, coordinating and planning rehearsals and risk
mitigation plans. Establish and maintain a single point of contact with FDA.
• Act as a role model, providing strategic advice within and outside of RA CMC, driving continuous
improvement and building the talent within the team through coaching and mentoring.