Job Description
Join BioNovate Solutions AG, a global leader in innovative pharmaceutical therapies, as we pioneer the next generation of life-changing treatments. We seek a dynamic Senior Regulatory Affairs Manager to drive our product approvals through complex international regulatory landscapes. This pivotal role combines scientific expertise with strategic compliance leadership in our state-of-the-art Basel headquarters.
As part of our global regulatory team, you'll collaborate with R&D, clinical, and commercial stakeholders to ensure seamless market access for our oncology portfolio. We offer competitive compensation, comprehensive benefits, and continuous professional development in an environment that values innovation and scientific excellence.
Responsibilities
- Develop and execute global regulatory strategies for Phase III-IV clinical products across EMA, FDA, and other key regions
- Lead preparation and submission of regulatory dossiers (MAA, NDA, BLA) ensuring compliance with ICH guidelines
- Manage lifecycle maintenance for marketed products including variation management and post-authorization safety surveillance
- Serve as primary regulatory liaison with health authorities during inspection and review processes
- Maintain expertise in evolving regulatory frameworks (GMP, GCP, pharmacovigilance) and implement best practices
- Mentor junior regulatory staff and cross-functional teams on compliance requirements
Qualifications
- Advanced degree (PharmD, PhD, or MSc) in Pharmacy, Life Sciences, or related field
- Minimum 8+ years in pharmaceutical regulatory affairs with 3+ years in senior management
- Demonstrated success in securing 5+ global product approvals in oncology or biologics
- Expert knowledge of EMA/FDA regulations and ICH guidelines
- Proven track record in managing complex regulatory inspections and audits
- Strong leadership experience with cross-functional international teams
- Excellent written and verbal communication skills with fluency in English