Careers
Regulatory Operations Manager (ROM-0209)
Ambit Biosciences is a privately-held biopharmaceutical company 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 Biosciences has the technology, the expertise and the vision to succeed in the kinase space. We are seeking a talented Regulatory Operations Manager to join our Regulatory team.
The Regulatory Operations Manager will have the key responsibility of preparing Investigation New Drug (IND) applications for Ambit Biosciences AC480iv program and AC430 programs. Other responsibilities will include, but not limited to:
- The production, assembly, document management and electronic publishing (eCTD format) of regulatory submission documentation (ie, INDs, NDAs, CTAs, MAAs, etc.).
- Ensuring compliance of submissions with all applicable regulations, guidelines, SOPs, and internal document specifications for regulatory submissions.
- Managing regulatory and project archives.
- Maintaining Electronic Document Management System and provide assistance and training to end users.
- Troubleshooting technical issues associated with submission-relevant documents and software.
- Actively participating on project teams advising on submission preparation timelines, processes and requirements.
The successful candidate will have the following qualifications:
- BS degree in Biological Sciences, Business Administration, Information Technology or related field preferred.
- Minimum of five (5) years pharmaceutical industry experience with at least four (4) years in regulatory affairs.
- Expertise in electronic submission requirements and eCTD publishing tools
- Strong knowledge of FDA electronic submission guidelines; ICH CTD and eCTD specifications requirements
- Fluency in MS Word and Adobe Acrobat document publishing.
- Ability to work both independently and within cross-functional project teams.
- Familiarity with global submission requirements a plus.
- Knowledge of regulatory affairs requirements for oncology drug products highly preferred.