Manager, Regulatory Affairs

**PRIOR PHARMACEUTICAL AND REGULATORY AFFAIRS EXPERIENCE A MUST!!**

• Coordination, preparation and review of regulatory submissions (INDs/NDAs)
• IND/NDA maintenance activities (amendments, including annual reports, safety reports, etc…)
• Interact with agencies as necessary and prepare responses to regulatory inquires
• Review technical, nonclinical, and clinical documentations (Investigator Brochures, nonclinical study reports, clinical protocols/study reports, CMC data, etc…)
• Act as a liaison with other departments and operations in the company to obtain required information and documentation
• Participate in strategic discussions and planning
• Provide regulatory support for development programs as a member of product development teams
• Assist in the development of global standards and SOPs
• Monitor and investigate daily federal register, FDA internet updates and trade press notices for change in regulations or regulatory policy that may impact internal operations
• Educate relevant staff on regulatory topics
REQUIREMENTS
• Minimum of a B.S. degree in a scientific discipline
• 5-10 years of industry experience in drug regulatory affairs
• Possess an understanding of the core processes of pharmaceutical R&D
• Knowledge of US and ICH regulatory guidances and the ability to assure compliance with regulations
• Positive attitude, self-motivated, assertive, detail-oriented, ability to work with minimal supervision and adapt to changing priorities
• Excellent organizational, interpersonal and communication skills (written and oral) required
• E-Submission (document management and publishing) experience is a plus, as is strong computer skills