Job

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.

RESPONSIBILITIES:

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)

.

REQUIREMENTS:

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