Senior Regulatory Affairs Specialist

• Excellent project management, negotiation, communication (written and verbal), and interpersonal skills
• Ability to communicate and work in a diverse team environment
• Effective interactions with technical personnel (Product, R&D, Clinical)
• Excellent team skills with ability to influence others without authority
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
• Ability to identify areas of concern in moderately complex projects and manage changes
• Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency, and driving for results
• Ability to write high-quality submission documentation
• Proficiency with Microsoft Office Suite, Adobe Acrobat, Electronic Management Systems
• Detail oriented with emphasis on accuracy and completeness