Contineum Therapeutics

Compliance

• 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

Senior Director, Regulatory Affairs