What are the responsibilities and job description for the Regulatory Affairs Manager position at Intellectt Inc?
Role : Regulatory Affairs Manager
Location : Santa Clara, CA - 95054-2807
Duration : 9 Months
Job Description :
Years Experience : 9
Education :
Bachelor's degree and 9 years of related work experience or an equivalent combination of education and work experience.
Advanced degree preferred.
Duties :
- Recruits, coaches and develops organizational talent.;
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.;
- Creates an entrepreneurial environment.;
- Provides direction and guidance to exempt specialists and / or supervisory staff who exercise significant latitude and independence in their assignments.
- May supervise non-exempt employees.;
- Keeps the organization's vision and values at the forefront of decision making and action.;
- Demonstrates effective change leadership.;
- Builds strategic partnerships to further departmental and organizational objectives.;
- Develops and executes organizational and operational policies that affect one or more groups by utilizing technical / professional knowledge and skills.;
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).;
- Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.;
- Develops, monitors and appropriately adjusts the annual budget for department(s).;
- Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.;
- Assess proposed regulations and communicate new requirements to the organization.
