Registration Information Management (20-00042) – NJ – East Hanover

As a member of the Registration Information Management (RIM) Team, responsible to support implementation of processes and procedures to ensure sustained compliance, at the global, regional and local level, with Health Authority regulations and internal *** expectations regarding the capture and management of the registration information for the global *** portfolio of products in current and upcoming systems.
Major Accountabilities
With guidance, directs and monitors HQ and CO compliance with internal procedures governing registration information management activities at the global, regional and local level. Provides training as needed
Expert in RA Systems and related tools that support registration information management processes worldwide
Provides counsel and guidance to RA CO colleagues regarding their accountability in the registration information process
Supports the regulatory strategy and contributes to the implementation of NovaRIM in collaboration with business owner and IT through e.g. data cleaning supervision on legacy systems, authoring of project-related documents etc.
Key Performance Indicators
Supports the achievement of consistent and sustainable performance against worldwide HA expectations and internal *** procedures governing registration information management:
Demonstration of a strong Quality and Compliance mindset
Strong project management, teamwork and customer focus
Contribution to business and quality benefits
Ability to establish good working relationships within RA and with other key stakeholders
Superior communication, facilitation, negotiation, and problem resolution skills
Demonstrated ability to continuously improve operations
Ability to influence change

2-4 years experience mainly in a regulatory environment & closely related areas (eg; Clinical Development, GCP, QA)
Must have knowledge of global regulatory requirements
Understands and able to assist RA in understanding compliance and quality drivers from a global perspective,
Country regulatory/pharmaceutical experience from outside Europe or US
Use of IT systems
Experience and ability to work in matrix cross-functional environment
Excellent verbal and written communication skills.
Proven negotiation skills
Demonstrated ability as a creative thinker
Logical and methodical, with attention to details
Source: Job Diva – Job Listing

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