about 2 months ago
A large Pharmaceutical client is looking for a Regulatory Affairs Director. This company are continuing to build on their strong pipeline in Oncology, so experience in this therapeutic area is needed. In this role, you will be exposed to multiple drugs at various stages of clinical pipeline and you also be tasked with spearheading projects and initiatives on a global scale!
- Lead a (or multiple) Global Regulatory team(s) to support and develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements
- You will be expected to help drive product development, global registration and maintenance of desired regional labeling, and effective regulatory agency interactions
- To develop and execute the global regulatory product strategy & lead global regulatory teams
- Represent Global Regulatory Affairs on the Product Strategy Teams and other key commercialization governance bodies
- Providing regulatory expertise and guidance to product teams on a regular basis
- Registration strategies and development plans aimed at achieving regulatory approval and product labeling.
- Lead the planning and implementing global regulatory filings
- Other duties, as required in this role and can be shared by our team
- A Doctorate degree or Master’s degree is highly preferred
- 4+ years’ worth of Global Regulatory experience in an Oncology setting
- 3+ years’ worth of managerial experience directly managing people and/or leadership experience in leading teams (and also projects)
- Experience developing novel global oncology product regulatory strategies including submissions and approvals of marketing applications
- Other expectations are included and can be shared by our team
If this opportunity interests you, please get in touch!