job title: submission specialist(gsk)

Job description

Site Name: Mexico City Torre Mitikah, Bengaluru Luxor North Tower

Posted Date: Jul 14 2025

In this role you will work with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), Global Submission Teams and Local Operating Company regulatory contacts to deliver End to End submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs (Standards Operating Procedures) and working practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Accountable to the Global Regulatory Lead and Global Regulatory staff for the delivery of lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.

• Responsible for the products regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc.)

• Perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.

• Liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.

• Be the contact for the GRL, maintaining the overall workplan (including relevant regulatory milestones according to the phase of development).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor degree or higher in biological or healthcare sciences.

• Strong experience within Regulatory Affairs in the Drug development environment and R&D in pharmaceutical industry.

• General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV .

• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.

• Advanced English.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.

• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.

• Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools.