426089 RIM & DO Sr. Specialist (Open)

Job Summary

The RIM & DO Sr. Specialist plays a crucial role in the Global Regulatory Affairs (GRA) team by providing subject matter expertise in Regulatory Information Management Systems (RIM). This position is responsible for the creation, maintenance, and quality assurance of regulatory information, ensuring compliance with data standards and supporting urgent submission activities. The specialist will also mentor junior colleagues and drive continuous improvement initiatives within the team.

Responsibilities

• Share subject matter expertise in Regulatory Information Management Systems and processes within Global Regulatory Affairs, focusing on the Regulatory Vault data model and legacy RIM systems.
• Create and maintain regulatory information in the RIM system, responding to urgent requests from end users for GRA submission activities.
• Complete complex or non-routine data maintenance tasks accurately and within agreed schedules.
• Provide primary support to end users of RIM systems, including guidance, ad-hoc training, and attendance at group meetings.
• Monitor data quality routinely, conducting root cause and trend analysis to identify corrective and preventative actions.
• Ensure compliance with data standards and defined procedures in personal work and that of junior colleagues.
• Streamline communication of regulatory information to Manufacturing and QA Release stakeholders to facilitate operations.
• Extract and transform raw data from RIM systems for KPI generation related to data quality improvement and performance monitoring.
• Support system validation activities, including User Acceptance Testing, and understand Change Control procedures for impact assessment.
• Establish and maintain procedural documentation such as SOPs, Work Instructions, User Manuals, and Handbooks.
• Foster a culture of continuous improvement within the team and support the implementation of system changes.
• Act as a RIM Subject Matter Expert, collaborating with GRA Process Leads and sharing technical expertise.
• Mentor and support new starters or junior colleagues in their roles.
• Ensure adherence to procedures in the maintenance of System Reference Data.

Qualifications

• Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Information Management).
• Strong understanding of Regulatory Information Management Systems and processes.
• Proficiency in data management and analysis.
• Excellent communication and interpersonal skills.
• Ability to mentor and train junior staff.
• Strong problem-solving skills and attention to detail.
• Familiarity with regulatory compliance standards and practices.
• Experience with data quality monitoring and improvement initiatives.

Preferred Skills

• Experience with Regulatory Vault and legacy RIM systems.
• Knowledge of Change Control procedures and User Acceptance Testing.
• Familiarity with KPI generation and performance monitoring.

Experience

• Minimum of 5 years of experience in Regulatory Affairs or a related field, with a focus on Regulatory Information Management.

Environment

• Work setting is hybrid, combining both in-office and remote work. The position is based in Bangalore.

Salary

• Estimated salary range: ₹4,000,000 per annum.