Regulatory Manager, Devices
1 month ago
**Site Name**: UK - Hertfordshire - Ware RD, Durham Blackwell Street, GSK House, USA - Pennsylvania - Upper Providence
**Posted Date**: May 2 2024
As Regulatory Manager for devices, you will manage the overall global regulatory and advocacy strategy for GSK’s portfolio of combination product devices (injectable and inhalation) across modalities and lifecycle
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**:
- Represent Global CMC Regulatory advising teams on global regulations and guidelines and providing strategic direction to cross-functional matrix project teams on medical device and drug/device combination product related topics.
- Ensure Global CMC Regulatory have processes and procedures in place to stay in compliance with those regulations.
- Be a key contact for external advocacy on device-related topics.
- When needed, participate in corporate evaluation and provide CMC Regulatory support/advice to in-licensing and divestment projects.
- Deliver CMC device-related regulatory strategy to support major submissions, RTQs, agency meetings, inspections (e.g. PAIs) or quality incidents (PIRCs). May include template creation and maintenance.
**_ Why you?_**
**Basic Qualifications & Skills**:
**We are looking for professionals with these required skills to achieve our goals**:
- Degree in Chemistry, pharmacy, engineering or closely related science, or equivalent
- Detailed knowledge of drug and device development, and manufacturing and supply processes, with direct involvement in regulatory submission preparation.
- Detailed working knowledge of worldwide CMC device-related regulatory requirements and successful track record of delivering dossiers that comply with these.
- Demonstrated ability to influence the global internal/external regulatory environment. Successfully influenced and negotiated issues with regulatory agencies and personnel in a variety of settings.
**Preferred Qualifications & Skills**:
**Please note the following skills are not necessary, just preferred, if you do not have them, please still apply**:
- Strong verbal and written communication skills with good attention to detail.
- Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Experience of being involved in/leading business critical initiatives within and external to the organisation.
**Closing Date for Applications - 16th May (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 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 thei
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