Regulatory Affaris Manager - Pharma - Bay Area

* Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs, CTXs, etc.), and prepare for the filing of subsequent licensing applications (NDA, MAA, e-CTD, etc.). Coordinate multiple submissions and projects effectively
* Maintain, organize, prepare and review, clear and effective submissions for existing and new products
* Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees; etc.)
* Direct interaction with regulatory agencies on defined matters. Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
* Additional Functions:

* Foster teamwork and improve intra-/inter-departmental communications
* Actively participate in and contribute to various meetings, e.g., project teams, departmental, etc., regarding regulatory and product development issues
* Position will regularly interact with all departments and all levels within a department
* Position may have direct reports

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Education Requirements: B.S. degree in sciences, preferably life science.
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