Director, Regulatory Affairs

Manages all regulatory activities for the company. Develops and implements regulatory strategies for internal product development. Works with partners representing company’s interests and support partners’ filing and regulatory activities. Provides counsel to other R&D and Commercial product team members. Ensures timely preparation of organized and scientifically valid regulatory documents and submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Contact person for regulatory agencies. Manages regulatory document system, including the archival storage and protection of regulatory filings.