Regulatory Associate Manager

Job Summary

The job holder is accountable for coordinating and tracking the flow of information into the relevant Regulatory Intelligence Database (RID) and business areas and providing oversight in terms of training and communication.

Key Responsibilities

• Coordination of surveillance of GxP related regulatory intelligence with a focus on GCP related Regulatory
• Coordination of triage and liaison between different Regulatory intelligence monitors
• Assist impact assessment leads in their activities on regulatory intelligence topics

• Assist in the efforts to decommission existing tools currently supporting regulatory intelligence in exchange for the new Freyr platform.
• Coordinate tactical surveillance for RI in International on the Freyr platform and identify gaps versus current ways of working and follow up with the ARIA/Sonata team
• Develop recommendations on the ways of working
• Specify, on; require assist and coordinate efforts to transition existing platform to the Freyr platform with an additional emphasis on the transformation of soft intelligence

• Assist in ensuring appropriate communication on the relevant platforms of selected regulatory intelligence topics

• Assist in ensuring proper archiving and documentation of selected impact assessments and consultations

• The JH will need to interact closely with LOC (local operating company) colleagues globally, to support the flow of regulatory intelligence on submission requirements into GSK s central intelligence database.

• Other tasks e.g. collecting responses, assisting in data collection, analysis and reporting to support position development

Basic Qualification

• Bachelor degree in biological or healthcare science

Preferred Qualification

• Minimum 5 years of experience with Global/ EM GCI /EU Regulatory submission experience - Knowledge of regulatory agency guidelines
• Knowledge of regulatory requirement data capture systems or similar databases
• Awareness of regulatory agency guidelines and expectations for submissions, particularly in the Emerging Market Region
• Working knowledge of electronic databases and basic knowledge of IT systems
• Basic understanding of the GSK portfolio
• Expertise with AI enabled tools and systems

Work arrangement

This role is based in India and follows a hybrid working model combining remote and on-site work.

What you will bring

You are collaborative and accountable. You pay attention to quality and detail. You explain regulatory requirements clearly and help others to act. You welcome feedback and look for ways to improve processes. You make decisions with patient safety and compliance at the centre.