Job

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.

Role:

• 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.

Experience needed

• 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!