21 days ago
An international biopharmaceutical company with an exciting oncology and rare disease pipeline is looking for a Senior Manager/Associate Director to join their regulatory team in the Bay Area! They are looking for a professional to help focus on pivoting their products into Phase III of clinical trials while also working on several early stage drugs (making for a very stacked pipeline).
If you're interested in learning more about this company please do get in touch! This company is actively hiring.
In this role you will be responsible for:
- Provide regulatory strategic input for drug development projects, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements
- Ensuring accuracy of all submissions in an appropriate and timely manner
- Building strong relationships and collaborating with FDA
- Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)
The client requires that all candidates have:
- Bachelor's degree or higher in relevant field
- 5-8 years of relevant experience
- Experience in oncology or rare disease preferred
- Track record of successful drug submissions/approvals
- Understanding of global regulations
- Strong communication skills
- Ability to work on multiple projects simultaneously