You will design regulatory strategies and lead submissions for diagnostics, ensuring compliance with local requirements while supporting training initiatives and managing interactions with health authorities.
Anforderungen
- •Minimum 4–6 years in pharmaceutical industry
- •Proven track record in regulatory projects
- •Strong understanding of global regulatory pathways
- •Familiarity with assay validation processes
Deine Aufgaben
- •Design and implement regulatory strategies for diagnostics.
- •Lead submissions for investigational and pre-market diagnostics.
- •Integrate regulatory input into drug development strategies.
- •Align with country teams to meet local regulatory requirements.
- •Prepare briefing materials and participate in health authority meetings.
- •Manage responses to health authority requests and follow-up activities.
- •Support compliance and training initiatives for diagnostics regulations.
Original Beschreibung
# Regulatory Diagnostics Senior Manager
**Basel (City)** | **Full time**
**Job Description Summary**
# LI-Hybrid
Location: Basel, Switzerland
Relocation Support: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support: please only apply if accessible.
Are you ready to shape the future of regulatory precision medicine? As a Regulatory Diagnostics Senior Manager at Novartis, you’ll play a pivotal role in advancing our innovative medicines portfolio by driving regulatory strategies for in-vitro diagnostics, including companion diagnostics. Collaborating with cross-functional teams and global partners, you’ll ensure compliance and accelerate access to life-changing therapies. This is your opportunity to make a meaningful impact on global health while working at the forefront of in-vitro diagnostics innovation.
**Job Description**
## Key Responsibilities:
- Design and implement regulatory strategies for precision in-vitro diagnostics and companion diagnostics globally
- Lead submissions for investigational and pre-market in-vitro diagnostics in collaboration with regulatory therapeutics leads
- Ensure integration of in-vitro diagnostics regulatory input into drug development strategies
- Align with country regulatory teams to meet local requirements and deliver timely submissions
- Prepare and coordinate briefing materials and participate in health authority meetings
- Manage responses to health authority requests and oversee follow-up activities
- Support compliance and training initiatives related to in-vitro diagnostics regulations and procedures
## Essential Requirements:
- Minimum 4–6 years of experience in the pharmaceutical industry with a focus on IVD/CDx
- Proven track record contributing to regulatory projects involving in vitro diagnostics or companion diagnostics
- Strong understanding of global regulatory pathways including IDE, NDA/BLA, 510(k), and PMA submissions
- Familiarity with assay validation processes and Clinical Laboratory Improvement Amendments (CLIA) standards
**Skills Desired**
Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management