The Associate Director or 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.
- 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 5+ years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
- Bachelor’s degree in a scientific discipline (microbiology a plus), advanced degree preferred.
- RAC certification from the Regulatory Affairs Professionals Society a plus.
- Experience preparing pre-IND meetings, IND submissions and IND maintenance.
- Strong attention to detail and the ability to manage multiple tasks.
- Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Excellent written and communication skills.