Legal Counsel – Clinical Trials & Regulatory (Basel)

Legal Counsel – Clinical Trials & Regulatory

Novartis AG in Basel is seeking a Legal Counsel to advise on clinical trial agreements, regulatory submissions, and health authority interactions across Switzerland and international markets.

You will work closely with Novartis's Global Drug Development organization, supporting the legal framework for clinical trials from Phase I through post-marketing surveillance, ensuring compliance with Swissmedic requirements and ICH-GCP guidelines.

What You Will Do

• Draft and negotiate clinical trial agreements (CTAs) with hospitals, CROs, and investigators
• Advise on regulatory submissions to Swissmedic, EMA, and FDA
• Support ethical and legal compliance for clinical research under the Swiss Human Research Act (HFG)
• Review informed consent forms and data protection aspects of clinical studies
• Advise on compassionate use and early access programs

• Draft and manage clinical trial agreements globally
• Advise on regulatory compliance for clinical development programs
• Support health authority interactions and inspection readiness
• Collaborate with medical, regulatory, and quality assurance teams
• Monitor regulatory developments affecting clinical research

• Swiss or EU legal qualification
• MLaw or equivalent; additional qualification in health/pharmaceutical law preferred
• 3-6 years of experience in life sciences, clinical trials, or pharmaceutical regulatory law
• Knowledge of Swiss HFG, ICH-GCP, EU Clinical Trials Regulation, and Swissmedic processes
• Fluent in English; German is required
• Experience in a pharmaceutical legal department or life sciences practice preferred