Manager, Regulatory Affairs Registration and Label Management

The Manager, Regulatory Affairs Registration and Label Management provides leadership and technical expertise for the creation, management and monitoring of Registration and Label Management metadata and documents. Serves as functional representative on relevant teams, leads project and process improvement initiatives, establishes strategies, and executes project tasks. May supervise staff.

Key Responsibilities:
Ÿ Develops strategies and identifies opportunities that may span multiple locations, functions or organizations related to Registration and Label Management systems such as TRACTS (The Registration and Compliance Tracking System) and GLS (Global Labeling System).
Ÿ Conducts risk assessments and develops contingency plans to accommodate unforeseen events.
Ÿ Monitors and participates in industry and agency initiatives around area of responsibility.
Ÿ Provides direction to department staff. Provides direction and oversight on all projects within area of responsibility.
Ÿ Interacts with all areas of regulatory affairs, affiliates and other departments within the greater pharmaceutical organization.
Ÿ Develops, executes and implements business processes.
Ÿ Responsible for assessment of metrics and reports to Senior Management on a monthly basis.

May have responsibilities for direct report employees or oversight of contract personnel. May indirectly manage the work of other department members.

Required Education:
Ÿ Bachelor's degree or High School diploma or equivalent and 10 years related experience

Preferred Education:
Ÿ Bachelor's degree, RAC certification

Required Experience:
Ÿ 5 years pharmaceutical or industry related experience.
Ÿ Experience working in a complex and matrix environment.
Ÿ Strong communication skills both oral and written.
Ÿ Experience/understanding/use of software tools.
Ÿ Proven leadership skills in a multi-disciplinary environment and presence.
Ÿ Keen awareness to cultural nuances; proven ability to work in a global environment.
Ÿ Strong attention to detail and problem solving skills.
Ÿ Ability to successfully interact with multi-divisional and multi-functional teams from across the globe.
Ÿ Ability to interact with senior management and executives.
Ÿ Effective use of negotiation skills to resolve issues.

Preferred Experience:
Ÿ Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.
Ÿ Demonstrated analytical capabilities.
Ÿ 2 years of experience managing employees.

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.