South San Francisco, CA, USA
15 days ago
Our client, a clinical-stage biopharmaceutical comapny based in San Francisco is looking to hire a senior level Regulatory Affairs professional. This Associate Director will help to develop and implement global regulatory strategies encompassing clinical, non-clinical and CMC disciplines to guide the development of multiple early development and late development drug candidates.
- To lead the preparation, assembly, review and submission of regulatory documentation such as INDs, IMPDs, orphan drug applications, annual reporting and pediatric plans.
- You will represent the Regulatory Affairs function in senior management meetings for regulatory strategies and aid the development of early and late stage development programs.
- You will focus on the execution of regulatory strategy with the help of cross-functional project teams and will also be required to interaction with global health authorities and corporate partners when required.
- You will be expected to lead the strategy and prepare for Health Authority meetings and also to serve as the primary liaison with Health Authority for assigned projects.
- Generally manage and build the regulatory group and manage the work of others by providing guidance to their teams.
- Bachelor’s degree in a life sciences, chemistry, or related discipline, an Advanced degree is highly preferred.
- 10+ years’ worth of experience in Regulatory Affairs.
- Experience working with US health authorities.
If this opportunity interests you, please get in touch!