|Global Regulatory Lead in Oncology Or Immunology (Multiple Roles)|
Boston, MA OR New York, New York
$200,000 - $250,000 + bonus + excellent benefits + relocation
Our client, a Global Pharmaceutical company that has recently come to an agreement to joint-venture with another major pharmaceutical brand in a development and commercialization strategy to directly benefit employees and patients! With this deal, the biopharmaceutical division is in need for strong Regulatory Strategists to lead from the Director-Level. Our client has iterated has iterated a request for the top talent in the United States and are willing to compensate accordingly to acquire the right person(s) for the roles.
The incumbent will be responsible for:
- Work as the US head for the development and implantation of Regulatory Strategy across US Brands
- Together with Global Regulatory Head, coordinate with Health Authority and regulatory advisory board meetings to support the project and its associated submissions
- Serve as the US Regulatory expert to sub-committees and teams. Work closely with global health authorities and regulatory teams.
- Ensure an understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly
- Provide an assessment of regulatory opportunities to potentially enhance the development pathway and of regulatory risks for the various options for regulatory development, as well as potential measures for risk mitigation
- This role is taken by regulatory experts who have regional responsibilities in a defined therapeutic area and have a position reporting to a Therapeutic Area Head
Our ideal candidate will possess:
- Ensure an understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly.
- Ensure top quality across all regulatory submissions.
- Plan for production of dossier(s) with the required content and quality to support the proposed label and product approval. The regional lead provides strategic oversight to the submission project manager and RISM on dossier content.
- Involve R&D QA in the development of project operational plans.
- Minimum of 10 years pharmaceutical industry experience and 8 years regulatory experience
- Experience in preparation and management of successful NDA/BLA submissions in US
- Experience liaising with FDA and leading teams to achieve successful Health Agency interactions
- Experience with the clinical trial phase of development, e.g. IND requirements
- Development and preparation of successful regulatory strategies and ability to contribute to the development and writing of a regulatory strategy document
- Experience leading a project with development activities in at least one regions
- Experience as a strong regulatory advisor to regulatory professionals as a key member of the RST