Job Description
Join our pioneering team at NovoMed Pharma AG, a global leader in innovative therapeutic solutions. As a Senior Regulatory Affairs Manager, you'll shape the future of healthcare compliance while working in our state-of-the-art Basel headquarters. We offer competitive compensation, flexible work arrangements, and opportunities to impact patient lives worldwide. Your expertise will drive our mission to deliver breakthrough treatments to markets across Europe, North America, and Asia.
Responsibilities
- Develop and implement comprehensive regulatory strategies for new drug applications and lifecycle management
- Lead interactions with global health authorities (EMA, FDA, PMDA) and ensure compliance with ICH guidelines
- Manage cross-functional teams to coordinate regulatory submissions and post-approval changes
- Monitor evolving regulatory landscapes and provide strategic guidance on market access pathways
- Oversee pharmacovigilance systems and adverse event reporting compliance
- Mentor junior regulatory professionals and drive continuous improvement in departmental processes
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 8+ years in regulatory affairs with 3+ years in managerial roles
- Proven track record of successfully submitting 5+ MAA/BLA/PMA applications
- In-depth knowledge of GMP, GLP, and pharmacovigilance regulations
- Certified Regulatory Affairs Professional (RAC) certification required
- Fluency in English and German; additional European languages advantageous
- Experience with eCTD submissions and regulatory document management systems