Senior Global Regulatory Lead
My client is and established global biopharma company that has retained us to fill a growth opportunity for a Senior Global Regulatory Lead to join their science driven, patient focused culture. In this role you will be leading strategy (US and Global) for innovative vaccine programs in development. Reporting to the Head of Global Regulatory Affairs, you will serve in a highly visible role and collaborate with a number of cross-functional stakeholders both internally and externally.
Responsibilities:
- Drive, oversee and ensure consistency of the global regulatory strategy and related activities associated with the projects under his/her accountability
- Key driver for the lifecycle of the asset
- Determine from a strategic and scientific perspective the content of technical, pre-clinical and clinical sections of product specific documents submitted to regulatory agencies worldwideto ensure that these documents meet high scientific standards and regulatory requirements
- Develop the asset specific regulatory strategy on a global scale
- Act as, or manage, the single point of Regulatory contact for Project Teams and/or Vaccine Leadership Teams as appropriate, along with other internal project related teams
- Provide input into all development stages of the products within a given product portfolio. Contribute, from an RA perspective, to the establishment of the product development strategy and its execution in order to ensure a complete and rapid development of the asset
- Global Regulatory Plan (GRP) ownership and accountability
Knowledge and Skills:
- Minimum BS/BA required; PhD or MD Preferred
- Minimum 10 years’ experience in managing regulatory projects and engaging directly with regulatory agencies required
- Direct experience in the development of medicinal products and obtaining licenses in different geographical areas
- Must have influenza and/or flu experience
- Must have experience managing global teams
- Must have FDA Pediatric Investigation Plan experience
- Must work well in a matrix environment