Global Regulatory Affairs Manager, Vaccines Siena

Global Regulatory Affairs Manager, Vaccines
Siena
Toscana, Siena

Site Name**: Belgium-Wavre, Italy - Siena, Poznan Business Garden, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, Zug House, Zurich Schaerenmoosstrasse

**Posted Date**: Jan 29 2025

**About the role**:

As a Manager, you will be responsible to the Global Regulatory Lead (GRL) for developing and implementing robust global and/or regional regulatory strategies for assigned vaccine assets.

**About the responsibilities**:

- Lead regulatory strategy on WHO submissions and prequalification.

- Lead the regulatory interactions and ensure the timely implementation of the regulatory strategy of our global health projects.

- Extensive collaboration within GSK, including working with local and regional commercial teams

- Proactively developing and implementing the regulatory strategy that will deliver the needs of the local region(s), with a global mindset.

- Lead regulatory interactions with Heath Authorities and the review processes

- Ensure compliance with global/ regional requirements at all stages of the product lifecycle

**About you**:

**Basic Qualifications & Skills**:

- Bachelor's degree in Biological or Healthcare Science

- Experience in all phases of the drug development process in regulatory affairs, with a focus on clinical

- Capable of leading development, submission, and approval activities in local region(s)

- Knowledge of clinical trial and licensing requirements in the US, EU, and other major countries/regions

- Knowledge of the vaccines field and ability to further develop necessary specialist knowledge for the product

- Ability to foster effective matrix working relationships and facilitate dialogue between the immediate team members and matrix team members to incorporate diverse ideas

**Preferred Qualifications & Skills**:

- PhD degree in Biological or Healthcare Science

- Experience in developing and implementing regulatory strategies to support clinical development of vaccines and their licensure

- Proficiency in digital fluency capabilities, including AI, to enhance project delivery and drive efficiency and innovation.

LI-GSK

GSKVaccines

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

**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.

**Important notice to Employment businesses/ Agencies