about 1 year ago
A small clinical-stage pharmaceutical client of ours has a new opening for a Manager/ Senior Manager of Regulatory Affairs located in New Jersey. They are a leader in the field of oncology therapeutics and their objective is to improve the quality of life for patients facing rare cancers.
The role would support the development and implementation of regulatory strategy and regulatory submissions reporting directly into the Head of Regulatory Affairs and QA. This position offers the opportunity to grow in knowledge and execution of Regulatory Affairs Strategy significantly.
- Provide regulatory support for all Regulatory Affairs activities liaising with other line functions
- Be responsible for the finalization and publishing of submissions to the FDA and other global regulatory authorities such as the EMA and Health Canada through appropriate regulatory portals
- Support all development and review of regulatory submissions including amendments, drafting cover letters, annual reports, filing FDA forms, etc.
- Develop and maintain regulatory submission databases
- Coordinate responses from colleagues to regulatory agencies in relation to clinical study submissions, drug development, launch readiness, and post marketing activities as necessary
- Bachelor’s degree in a scientific or life sciences discipline
- Previous experience working on the execution and publishing of NDA submissions
This role is actively interviewing candidates, please send your CV to Marissa, at firstname.lastname@example.org for consideration.