Job Description
Join our global leader in innovative healthcare solutions as a Senior Regulatory Affairs Specialist. You'll be instrumental in navigating the complex regulatory landscape for our cutting-edge oncology portfolio, ensuring compliance with EMA, FDA, and global health authorities. This role offers the opportunity to shape regulatory strategies for life-changing therapies while working in a collaborative, research-driven environment.
Responsibilities
- Develop and execute global regulatory strategies for new drug applications and lifecycle management
- Prepare and submit dossiers to health authorities including CTD/eCTD formats
- Lead cross-functional teams to ensure regulatory compliance across product lifecycle
- Monitor regulatory changes and provide strategic guidance to internal stakeholders
- Represent company at health authority meetings and industry conferences
- Maintain robust regulatory intelligence systems and compliance documentation
Qualifications
- MSc/PhD in Pharmacy, Life Sciences, or related field
- 5+ years' regulatory affairs experience in pharmaceutical industry
- Proven expertise in oncology therapeutic area
- Strong knowledge of ICH guidelines and global regulatory frameworks
- Excellent written communication skills for dossier preparation
- Certified Regulatory Affairs Professional (RAC) preferred
- Fluency in English and German; additional languages advantageous