Ra Cmc Associate Director
Vor 2 Tagen
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 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.
**Role will be filled at level commensurate with experience**
Your Responsibilities include but are not limited to:
- Formulate, lead and drive global CMC regulatory strategy for Respiratory/Neuroscience projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
- 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
- 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
**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:
- 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 ability to deal with complex CMC regulatory issues and requirements
- Proven 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
Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis
**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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