Ra Cmc Associate Director
vor 13 Stunden
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 Biologics, mRNA/siRNA and/or Cell&Gene 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, mRNA/siRNA and/or Cell&Gene projects/products drawing on substantial regulatory expertise with a focus on in-novation, maximizing the business benefit balanced with regulatory risks and compliance.
- Identify the required documentation and any content, quality and/or timeliness issues for glob-al submissions and negotiate the delivery of approved technical source documents in accord-ance with project timelines.
- Represent Global Regulatory CMC on cross-functional project teams and maintain collabora-tive 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.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
What You’ll Bring To The Role
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; lead-ing, 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
Desirable Requirements
- Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, 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 abil-ity 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.
**Division**
Global Drug Development
**Business Unit**
REG AFFAIRS GDD
**Country**
Switzerland
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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