Global Regulatory Affairs Manager

vor 2 Wochen

Baar, Schweiz GSK Vollzeit

**Site Name**: UK - London - Brentford, Baar Onyx

**Posted Date**: Mar 22 2024

Global Regulatory Affairs Manager - Oncology

We are looking for a driven and motivated Global Regulatory Affairs Manager to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

**In this role you will**
- Ensure appropriate interaction with the cross-functional team, global/regional counterparts and with local operating companies
- Ensure compliance with global/ regional requirements
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset

**_ Why you?_**

**Basic Qualifications & Skills**:
**We are looking for professionals with these required skills to achieve our goals**:

- Bachelor degree in biological or healthcare science
- Experience of the drug development process in regulatory affairs
- Capable of leading development, submission and approval activities in different region(s) globally
- Knowledge of clinical trial requirements at least in one the region (EU or US) and ideally knowledge of other key Agency processes globally.
- Ability to develop necessary specialist knowledge for the product in a specific oncology disease area

**Preferred Qualifications & Skills**:
**Please note the following skills are not necessary, just preferred, if you do not have them, please still apply**:

- PhD in biological or healthcare science
- Excellent communication skills
- Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
- Ability to use a range of sources to weigh benefits and risks before making decisions.
- Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change.
- Able to develop own networks within GSK and of securing appropriate support and outcome for a project.

**Closing Date for Applications - 5th April 2024 (COB)**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

Find out more:
Our approach to R&D.

**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 reflect

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