Job Summary   Reporting to the Director of Regulatory Affairs based in France, the Regulatory Affairs Manager will assist with and manage regulatory submissions in the US and help develop strategies that are in accordance with therapeutic indications and corporate objectives.  Primary responsibilities include preparing regulatory documents, serving as regulatory contact in the US for designated projects, serving as regulatory contact for FDA, developing processes and timelines in support of designated regulatory activities, and tracking submissions.  Job Responsibilities  Participate in cross functional global project teams to deliver successful submissions/filings and outcomes with Health Author