Pre-Clinical & Clinical RA Director

Pre-Clinical & Clinical RA Director
Department: Regulatory Affairs
Reports to: VP RA
Primary purpose and function of this position:
Support pre-clinical and clinical aspects of product development with focus on authoring/review of M4 & M5 in NDA/MAA and any other regulatory documents (such as CTA/IND/Briefing books, etc.).
· Routine review of relevant guidelines and/or publicly available regulatory data of reference products, publications, etc.
· Review of pre-clinical and clinical protocols & reports derived from the respective disciplines to confirm compliance with guidelines and scientific advice (if applicable)
Other Major duties and responsibilities:
· Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
· Review strtegic documents pivotal for NDA/MAA submission (protocols, reports, etc.)
· Create and maintain regulatory documentation (such as briefing books, IB, IND).
· Prepare and attend consultation meetings with regulatory agencies.
· Put together regulatory submissions to FDA, EU and other territories regulatory entities.
· Track, interpret and advise on US and European regulations, guidelines, procedures and policies within the scope of the company
· Other duties as assigned