Job Description
Join Novartis, a global leader in pharmaceutical innovation, as we pioneer breakthrough treatments that transform patient lives. We seek a visionary Senior Regulatory Affairs Manager to drive compliance excellence and accelerate market access for our cutting-edge therapies. In this pivotal role, you'll navigate complex regulatory landscapes, ensuring adherence to EMA, FDA, and global health authority standards while collaborating with cross-functional teams to bring life-changing medicines to patients worldwide.
Our Basel hub offers a dynamic environment where scientific rigor meets operational excellence. You'll lead strategic regulatory submissions, manage product lifecycle compliance, and mentor a high-performing team—all while contributing to our mission of reimagining medicine. This position includes competitive benefits, continuous learning opportunities, and the chance to impact global healthcare policy.
Responsibilities
- Lead end-to-end regulatory strategy and submissions for assigned therapeutic areas
- Ensure compliance with global regulatory requirements (EMA, FDA, ICH guidelines)
- Manage product lifecycle compliance from preclinical to post-marketing stages
- Collaborate with R&D, Clinical, and Commercial teams on regulatory strategy
- Represent company at health authority meetings and industry forums
- Mentor junior regulatory professionals and develop team capabilities
- Monitor regulatory landscape changes and advise on compliance implications
Qualifications
- MSc/PhD in Life Sciences, Pharmacy, or related field
- 8+ years regulatory affairs experience in pharmaceutical industry
- Proven expertise in EMA/FDA submissions and health authority interactions
- Deep knowledge of GMP, GCP, and pharmacovigilance regulations
- Strategic thinking with ability to manage complex global projects
- Exceptional communication skills in English (German advantageous)
- Experience leading cross-functional regulatory teams
- Track record of successful product approvals and compliance milestones