Careers
Manager, Regulatory Operationse - MRO-417
Ambit Biosciences is engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit currently has two compounds in early stage clinical development. We are seeking a talented Manager, Regulatory Operations to join our Regulatory team.
The Manager, Regulatory Operations responsibilities will include, but not limited to:
- Establishing regulatory operations function at Ambit
- Setting up document management system (electronic and hardcopy)
- Preparing, submitting and archiving global regulatory documents, eg, INDs, IND Amendments, Annual Reports, CTAs etc. to support clinical studies
- Creating standard templates in accordance with ICH documentation guidelines
- Reviewing and editing documents to ensure consistency and regulatory compliance
- Representing regulatory on project sub- teams, e.g., CMC, Clinical
- Providing ongoing tactical regulatory support for development programs
The successful candidate will have the following qualifications:
- BS in scientific or healthcare discipline
- Minimum of five (5) years pharmaceutical industry experience with at least four (4) years in regulatory affairs.
- Ability to work both independenstly and within cross-functional project teams
- Experience with setting up and maintaining electronic document management system
- Knowledge of regulatory affairs requirements for oncology drug products highly preferred