Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Executive Regulatory Science Director, Oncology provides global strategic regulatory expertise and oversight to support the research, development and commercialisation of products across both small molecules and biologics within the Oncology Regulatory Science and Strategy (ORSS) group.
How you will make a difference:
- Partner with and mentor the Regulatory Affairs Directors aligning on global innovative regulatory strategies for products.
- Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
- Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
- Collaborate with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
- Define and drive disease area global regulatory policies and priorities.
- Lead budget management, resource planning and recruitment of staff.
- Review and approve high-level documents for global regulatory submissions as well as core prescribing information.
- Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practises and knowledge and using existing tools.