Regulatory Associate Manager

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.

Apply now
If you want to grow your regulatory career and help deliver work that makes a difference, we would like to hear from you. Please apply and tell us how your experience will help deliver high-quality regulatory submissions.

Skills

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 [email protected] to discuss your needs.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.