Responsibilities
- Serve as the regulatory representative on study and program teams during clinical development and product lifecycle phases
- Develop or evaluate regulatory submissions essential for international product advancement, such as initial INDs/CTAs, DSURs, amendments, meeting requests, briefing packages, iPSP/PIP plans, and NDA/MAA dossiers
- Supervise external regulatory submission vendors to ensure submissions are technically sound, complete, compliant, and filed on schedule
- Direct the creation of global regulatory filings and manage interactions with health authorities, including responses to information requests related to clinical trials
- Lead, manage, and develop direct reports to support achievement of departmental and organizational objectives
- Support corporate compliance efforts by contributing to SOPs, documentation standards, and regulatory process improvements
- Evaluate clinical study materials—including protocols, consent forms, investigator brochures, site documents, and regulatory forms—for adherence to regulatory requirements
- Maintain up-to-date knowledge of U.S. and international regulations affecting products and internal processes
Work Arrangement
Hybrid
Responsibilities
- Represent regulatory on study and program teams throughout study conduct and product development
- Prepare and/or review regulatory documents required for global product development (e.g. New IND/CTAs, DSURs, IND Amendments, health authority meetings and briefing documents, iPSP/PIP, NDA/MAA)
- Provide oversight of regulatory submissions vendor to assure technical accuracy, compliance, completeness, and timely regulatory agency submissions
- Lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required
- Manage and mentor direct reports to achieve department and corporate goals
- Provide regulatory support for company compliance initiatives, including SOP development, and documentation initiatives, etc.
- Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance
- Keep current on US and OUS regulations that apply to company products and processes
