About the ABPI
The ABPI exists to make the UK the best place in the world to research, develop and access medicines and vaccines to improve patient care. We represent companies of all sizes which invest in making and discovering medicines and vaccines to enhance and save the lives of millions of people around the world.
In England, Scotland, Wales and Northern Ireland, we work in partnership with governments and the NHS so that patients can get new treatments faster and the NHS can plan how much it spends on medicines. Every day, our members partner with healthcare professionals, academics and patient organisations to find new solutions to unmet health needs.
The ABPI plays a key role in shaping how the UK licences and ensures timely access to new medicines, through dialogue across MHRA, HTA bodies and the NHS. The Regulatory Policy Manager works on policies supporting regulation and licencing, in order that members see the UK as a predictable and attractive launch market. The key relationship for the role is with the MHRA, where ABPI seeks to play a supporting role as a key trade body and provide the voice of the pharmaceutical industry. In this regard the ABPI recently published an influential report to help shape a globally leading UK regulatory framework for innovative medicines (Enhancing the role of UK medicine regulation).
Primary objectives/ responsibilities
* Support the Director of Regulatory Policy & Early Access in the delivery of policy and related ABPI priorities
* To be a key contact with members, and maintaining relationships with external stakeholders in regulatory policy areas
* Support ABPI projects requiring regulatory policy input including consultation responses
* Support the broader regulatory science area through regulatory policy as required, and the delivery of the ABPI Regulatory Science Symposium
* Represent the ABPI on relevant external committees and task and finish working groups to deliver agreed policy objectives
* Liaise with and assist key ABPI stakeholders on regulatory policy development for early access, clinical research & licensing
* Deliver the administrative and governance support of the ABPI member Expert Networks, and support the Regulatory Science Board Sponsored Group, to ensure effective industry engagement and representation
* Provide technical input to support the Director of Regulatory Policy & Early Access and other internal and external stakeholders as required
* Provide leadership as required of ABPI member Project Teams
Experience and skill set
* Relevant experience in a regulatory role in the Life Sciences Industry or similar role in government, academia or not for profit organisations
* Knowledge of the UK and/or international regulatory framework and drivers for the evolution of regulatory science
* Demonstrable experience of policy development and delivery
* Experience working on externally focused project teams and project management
* Experience of managing different inputs in order to shape and deliver policy
* Ability to present to senior groups of stakeholders/ ABPI Board
* Ability to lead and work cross functionally with internal colleagues in this policy space
* Ability to explain technical issues to non-technical audiences
* High level of IT literacy and competent in the use of Microsoft Office packages including Word, PowerPoint, and Excel
To apply
For a full job description and salary and benefits information or to apply for this opportunity please submit your CV with a covering letter
For more information, please contact Joshua at Joshua@ellwoodatfield.com.