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Regulatory Submission Lead-Submission Delivery Excellence-LCM

hace 3 semanas

Xoco CDMX, México GSK A tiempo completo

Site Name: Mexico City Torre Mitikah

Posted Date: Nov

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.

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

Mentors/coaches/trains other team members and reviews work to ensure right first-time submissions

Responsibilities

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 Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
  • May be responsible for leadership of relevant submission team for product 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)
  • May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
  • May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
  • May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
  • May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

  • Bachelor degree or higher in biological or healthcare science
  • General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV
  • Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
  • Ability to work in a matrix environment.
  • Advanced english

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.

Your application is voluntary; therefore, you understand and consent that GSK, located at Real Mayorazgo 130, Torre M, Piso 20, Col. Xoco, Benito Juárez, Mexico City, will process your personal data to evaluate your candidacy in accordance with the candidate privacy notice, which can be consulted at Candidate Privacy Notice. Among the information you provide for this purpose, you may choose to give us personal data that will help ensure an inclusive selection process. Rest assured that your information will be treated with the utmost confidentiality, in compliance with applicable regulations, and will not be available to hiring managers or anyone outside the recruitment team. Help us maintain, together, an inclusive and welcoming environment. By submitting information, I confirm that I agree that it will be processed in accordance with the stated privacy notice.

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