Regulatory Affairs
Where
- South San Francisco, CA
What you'll be doing
- Leading selected investigational aspects of a regulatory program currently in phases 1b through 3 with an emphasis on some specific indications and strategic agility to work with multidisciplinary clinical development teams. Taking lead as liaison with US and/or Canadian health authorities under leadership of a global regulatory leader on the molecule. Participating in a collaborative regulatory team working on many aspects of the parent program. Specifics of the assignment will be detailed upon identification of the candidate. Delivering would likely include original IND(s) and integration with existing investigational and NDA filing team activities (the latter being managed by others on the team for later developed indications).
What your background should be
- Experience level should be minimum of 5-7 years preferred. CMC and safety reporting are handled by different parts of the organization, so only those with clinical development experience should be recommended.
Required Schooling / Training
- Not specified
Who is the client company
- This is a consulting company focused on providing expertise in drug safety, risk management, regulatory affairs and quality assurance.
- If you are interested in this position, send your resume to apply@kochdavis.com
