Associate Director, Regulatory Affairs Registration and Label Management
- Serves as subject matter expert (SME) related to Labeling Operations and Labeling Compliance to develop strategies, processes, and reporting tools.
- Leads cross functional and cross divisional teams for process improvement initiatives and develops implementation plans and coordination of tasks. Serves as strategic regulatory partner to IT for system initiatives/issues. Leads cross-functional teams to resolve product labeling process and compliance issues.
- Provides leadership and technical expertise for the creation, maintenance or management of product labeling in systems (e.g. document management systems, labeling systems, etc.) to meet regulatory requirements.
- Drives process improvements within cross-functional teams, including continuous improvement throughout the department by employing quality principles.
- Identifies and evaluates industry trends and develops and implements policies, procedures and system improvements.
- Maintains an awareness of legislation and assesses its impact on department strategies, systems and processes.
- Effectively plans and prioritizes workload, follows up to assure success, and works to bring issues to resolution. May manage staff.
- Provides operational metrics.
- 8 years in pharmaceutical or industry related experience.Proven 3 years in a leadership role with strong management skills. Demonstrated analytical capabilities
- Experience working in a complex and matrix environment.Strong communication skills, both oral and written.Demonstrated ability to lead multi-divisional and multi-functional teams.
- Experience in project management, Experience/understanding/use of software tools, International Regulatory experience
- Proven leadership capabilities in a multi-disciplinary environment4 years' experience managing employees
- Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.