Site Name: UK – London – New Oxford Street, Baar Onyx, UK - Hertfordshire - Stevenage
Posted Date: Nov 15 2024
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:
* 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:
* 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.
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