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Regulatory Affairs Director

hace 3 meses

Tlahuac, México GSK A tiempo completo

**Site Name**: Mexico - Federal District - Mexico City

**Posted Date**: Mar 6 2024
**_
Your Responsibilities_**:
Are you looking for an opportunity for Strategic planning and execution for obtaining the approval of Vaccines, Pharmaceutical and ViiV pipeline, as well as for new projects? If so, this is the role for you.

YOU will need the ability to Develop regulatory strategies for our pipeline, including risk management and lifecycle management of Marketing authorizations, including variations and renewals, supporting supply continuity and updating the product labelling to reflect the appropriate risk/benefit ratio.

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

- Conducting the lifecycle management of 90 Marketing Authorizations, including but not limited to license variations and renewals. Provide direct support to GSK alliance markets to ensure successful implementation of promotional tactics.
- Looking for the harmonization of the local regulation with the recognized international standards.
- Providing regulatory support for commercial & supply initiatives.
- Participating in the pharmaceutical chamber and trade associations meetings and initiatives to influence the regulatory environment.
- Generating or update the artwork of the Vaccines, Pharmaceutical and ViiV products.
- Effective budget management.
- Providing regulatory support for commercial & supply initiatives.
- Member of the Emerging Markets Regulatory Affairs &Local Leadership Team.

**_ Why you? _**

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

- Bachelor’s degree in Chemistry or Pharmacy or a related degree (e.g., Pharmaceutical Engineer, Pharmaceutical and Biological Chemistry).
- 8 years of experience in Regulatory Affairs and Quality with special focus on Vaccines and Pharmaceutical products.
- Exceptional project management skills and history of delivering results.
- Excellent interpersonal skills with the ability to work in a team.
- Language: strong communication skills in Spanish and English (both written and oral).
- Experience successfully working in a matrix organizational and cross functional team.
- Proactive attitude, ambition, and the confidence necessary to achieve exceptional goals is necessary for success in this position.

**Preferred Qualifications**:

- Master’s degree in science.
- Project management
- Strategic thinking and risk 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 positively impact the health of 2.5 billion people by the end of 2030.

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.
- **_This is a job description to aide in the job posting, but does not include all job evaluation details._**

**Why Us?**

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Important notice to Employment businesses/ Agencies