Director, Regulatory Affairs will assist with the regulatory leadership and management of one of the company’s early stage development programs and will work closely with Clinical, Research & Development, Pharmaceutical Development, Quality and other disciplines to ensure an effective linkage of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. Title depends on prior experience.
- Lead and manage the compilation and submission of new Investigational Drug Applications (INDs) and Clinical Trial Applications (CTAs).
- Facilitate cross-functional writing of nonclinical reports, IND sections, protocols, etc. supporting regulatory submissions etc., as well as write and edit documents as needed.
- Assume responsibility for IND maintenance, including routine and more substantial IND amendments.
- Coordinate and lead communication with the relevant personnel at the FDA.
- Support the preparation and conduct of Agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.
- Support late stage development, including supporting the development of NDA/MAA and other global filing plans.
- Manage contract staff and vendors as needed to support regulatory activities.
- Coordinate with Regulatory Operations in the generation of documents suitable for electronic filings
- Minimum 7-10 years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
- Bachelor’s degree in a scientific discipline, advanced degree preferred.
- Experience preparing pre-IND meetings, IND submissions and IND maintenance.
- Strong attention to detail and the ability to manage multiple tasks.
- Ability to represent Regulatory Affairs at team meetings and meetings with strategic partners
- Excellent written and communication skills.
- RAC certification from the Regulatory Affairs Professionals Society a plus.