Regulatory Specialist, Rim

**Site Name**: Mexico City Torre Mitikah

**Posted Date**: May 31 2024

The purpose of this role is to ensure that GSK product (Pharmaceuticals and Vaccines) registration information and regulatory records are maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply. This data also supports the efficient operational management of the Regulatory function, worldwide. The role provides operational support to RIMS (Regulatory Information Management) end-users.

The information managed is the formal record of GSK regulatory activity (documents and data) and is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK.

**_ Your Responsibilities: _**This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

- Accurate completion of routine data maintenance tasks to agreed schedule.
- Ensure own work is compliant with data standards and defined procedures.
- Ensure defined quality control procedures are followed.
- Capable of performing routine data extraction from RIMS (Regulatory Information Management) to support KPI generation.
- Maintain knowledge of GSK standards and procedures associated with RIMS (Regulatory Information Management) and contribute to the definition of new and revised procedures to improve quality and effectiveness.
- Indexing, abstracting and quality assurance of US/UK submissions and associated correspondence into established regulatory document management system(s).
- Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
- Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
- Working on Special projects as required in response to internal and external customer requests.
- Support for IT related activities
- Accurate completion of routine data maintenance tasks to agreed schedule.
- Ensure own work is compliant with data standards and defined procedures.
- Ensure defined quality control procedures are followed.
- Ensure CQA and PVQA data is entered accurately into the audit management system and within the required timelines working on Special projects as required in response to internal and external customer requests.

**_ Why you? _**

**_Basic Qualifications:_** We are looking for professionals with these characteristics to achieve our goals:

- Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
- 0-3 years’ experience in Regulatory Affairs Data Management (in pharmaceutical industry, life sciences research or regulatory)
- Advanced English
- Availability to work in office 2 days per week.
- Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
- Proven ability to work on multiple projects simultaneously.
- Service orientation, customer-focused

**_ Preferred Qualifications:_** However, if you have the following, it would be a plus:

- Veeva Vault
- Project Management

**_ Why GSK? _**

Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Why GSK?**

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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use