Regulatory Affairs Specialist

hace 1 semana

Xoco, México GSK A tiempo completo

**Site Name**: Mexico City Torre Mitikah

**Posted Date**: Jun 21 2024

Regulatory Affairs Specialist

This position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.

**Responsibilities**:

- It is the responsibility of the collaborator to know and comply with each one of the local and/or corporate, national and/or international laws, policies and guidelines applicable to their position.
- Actively participates in projects to improve your area and your site.
- Complies with the training and development plan assigned to their position.
- Develops regulatory strategies (Third Parties, Demand and Commercial) together with the Regulatory Affairs Manager.
- Provide local or international contacts with the specific requirements of the Mexican market.
- Coordinate and execute activities related to the preparation and submission to the Ministry of Health in Mexico on:

- Registration renewals.
- Variations to the registration conditions: change in formula, active ingredient, manufacturing process, packaging, shelf-life extension, line extensions, manufacturing sites and new indications.
- Product Information update.
- Specific cases such as technical queries, meetings, etc.
- Responses to the Health Authority Questions.
- Monitoring and response to commitments.
- Updating of the information in the dossier in accordance with the Mexican Regulation.
- Maintenance and updating of applicable systems (Submission Plan, Veeva, Filestorage, etc).

**Your Qualifications**
- Professional background in pharmaceutical chemistry or related field
- 1 year experience in regulatory affairs or release of biological products
- Knowledge of Office package
- Intermediate to advanced level of English
- Experience in Pharma

¿Por qué GSK? Nuestros valores y expectativas son el pilar en todo lo que hacemos y definen nuestra cultura para que en conjunto podamos impactar positivamente la vida de pacientes y consumidores y hacer de GSK un ambiente brillante de trabajo. Como parte de GSK, te motivaremos a ser quién eres dentro de un ambiente diverso e inclusivo, enfocado en tu bienestar y que te permita sentirte bien, disfrutar y aprovechar las oportunidades que ofrecemos para desarrollarte y seguir creciendo. En GSK creemos que cada persona ofrece algo único, y que cuando combinamos nuestros conocimientos, experiências y estilos, el impacto es increíble. Únete a nosotros para hacer la diferencia y juega un papel importante en beneficio de millones de pacientes y consumidores a nível mundia

**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 of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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