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Baar, Schweiz GSK Vollzeit**Site Name**: UK - London - New Oxford Street, Baar Onyx, Home Worker - GBR, Upper Providence, Wavre **Posted Date**: Feb 19 2025 **415150 Manager/Associate Director, Clinical Pharmacology (Lifecycle Management) - 2 Year Fixed Term Contract/Secondment** Are you energized by a role that requires strategic thinking and extensive internal and external...
Associate Director, Oncology Therapeutic Group
vor 3 Wochen
**Site Name**: UK - London - New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage
**Posted Date**: Nov 15 2024
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. 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.
As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data.
You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies.
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**
- Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
- Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
- Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data.
- Lead interactions with local/regional regulatory authorities.
- Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects.
- Ensure compliance with global/regional requirements at all stages of the product life cycle.
**_ Why you?_**
**Basic Qualifications & Skills**:
**We are looking for professionals with these required skills to achieve our goals**:
- Bachelor’s degree in biological or healthcare science.
- Experience in the drug development process within regulatory affairs.
- Proven ability to manage development, submission, and approval activities in different regions 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**:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Knowledge of all phases of the drug development process in regulatory affairs.
- Capability to lead regional development, submission, and approval activities in local region(s).
- Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally.
- Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine.
- Creative regulatory problem-solving capabilities, balancing agency expectations and compliance
**Closing Date for Applications - 31 Jan 2025 (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 GSK?**
**Uniting scien
