Regulatory Associate Manager

GSK; Bengaluru; Hybrid; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

GSK in Bengaluru, India, invites a Regulatory Intelligence Coordinator to manage flow of information into RID, support training and communication, and liaise with global LOC teams. The role emphasizes surveillance of GxP regulatory intelligence, transition to Freyr platform, and ensuring documentation and data integrity.

The role requires a Bachelor degree in biological or healthcare science and is based in a hybrid model combining remote and on-site work in India.

Qualifications

• 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

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
• Specifically, 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

Skills

Regulatory submission experience

Regulatory guidelines knowledge

AI-enabled tools

IT systems familiarity

Cross-functional collaboration

Education

Bachelor degree in biological or healthcare science

Tools

Regulatory data capture systems

Job description

Job Description:

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D
Position 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

  Specifically, 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [e-mail] to discuss your needs.