Regulatory Specialist - I

Location

Bangalore | India

Job description

Regulatory Specialist RIMS is responsible for delivering the following key services to GRA colleagues in support of achieving GRA business objectives:

Responsibilities of this role are:

• Supervise, mentor and support the work of junior colleagues.
• Supports in resource analysis to the manager to ensure obligations can be met.
• Accurate completion of more complex or non-routine data maintenance tasks to agreed schedule
• Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems and as well as understand the upcoming system changes and be part to propose or implement those changes ensuring readiness of the RIM team.
• Provision of primary support to end users of RIM systems and processes to enable efficient ways of working including: provide basic guidance, ad-hoc training, attendance at group meetings, provision of appropriate Reports etc
• Monitoring data quality routinely in order to identify and mitigate issues. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions
• Creation and maintenance of records (data and documents) within the companys Regulatory Information Management System (RIMS) with information provided on demand by end users for all GRA Submission activities - typically supporting urgent timebound requests.
• Streamlining regulatory information communication to Manufacturing and/or QA Release stakeholders to facilitate Supply Chain and QA Release operations
• Ensuring appropriate procedures are followed in the maintenance of System Reference Data
• Provision of support for system validation activities such as User Acceptance Testing, with a foundational understanding of the requirements of the Change Control procedures for enabling full impact assessment of any system/process change.
• Responsible for establishing & maintaining appropriate written standards where needed: SOP, WI, GUI, QRG & to continuous improvement projects and/or coordinating Key User fora, as RIM SME

Job tags

Salary