The Director, Regulatory Affairs will assist with the regulatory strategy 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. This is an exciting opportunity to play a key role in supporting our product pipeline through the Regulatory process into commercialization.
- 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/CTA 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 or other Health Authority, as required.
- 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.
Successful candidates will be able to demonstrate:
- BA/BS degree is required; Advanced degree (M.S., Pharm.D. or Ph.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- Minimum 7-10 years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
- Experience preparing pre-IND meetings, IND submissions, and IND maintenance.
- RAC certification a plus.
- NDA/MAA experience, a plus.
- Strong attention to detail and the ability to manage multiple tasks with competing timelines.
- Ability to represent Regulatory Affairs at team meetings and meetings with strategic partners.
- Ability to independently solve problems and work cross-culturally.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Proficiency with commonly used word processing, database systems, document management, and other software.