Back to Previous Page
Job ID 302649BR Position Title RA CMC Associate Director Apply to Job
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 pa-tients’ lives and we need your help. As a 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 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 Cell and Gene Therapies draw-ing on substantial 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, coordina-tion, submission) for assigned projects/products, while applying the global strategy into sub-missions.
• 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 accord-ance with project timelines.
• Author and/or review high-quality CMC documentation for Health Authority submissions, estab-lishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
• Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA.
• Provide strategic advice and direction within the department and cross-functionally through specialized assignments.
What You’ll Bring To The Role
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.
• Excellent written/spoken communication, and negotiation skills
• Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biol-ogy, Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 8 years regulatory experience preferred and/or pharmaceutical industry experience
• Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
• Proven ability to critically evaluate data from a broad range of scientific disciplines.
Why consider Novartis?
799 million and counting. That’s how many lives our products touch, and while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine. Division Global Drug Development Business Unit REG AFFAIRS GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
Apply to Job
Access Job Account
- Jump to Comments