We are looking for an Associate Director who has working experience at filing and liaising of regulatory submissions and meetings with health authorities, leading for US FDA and participating in EMA interactions. Therapeutic experience at oncology or new therapeutic modalities is preferred.
The Associate Director will be responsible for:
- Developing Regulatory strategies for U.S. based Oncology product line
- Interface with global regulatory authorities and consultants as needed
- Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments and NDA/BLA/MAA
- Provide regulatory oversight of maintenance submissions (DSUR, PSUR, Annual Reports, etc) of assigned U.S. based projects
- Coordinate with relevant cross functional teams within the organization related to product development
The Associate Director should have the following qualifications:
- 6-8 years within Regulatory Affairs preferred
- Hands on early development experience within Oncology specifically
- RAC certification preferred
If you are interested in learning more about this opportunity, please apply here.