Devices Specialist, Global Cmc Regulatory Affairs' - Ware, United Kingdom - GSK

GSK

Verified Company

Ware, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Site Name:
UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence

Posted Date:
Jan

Devices Specialist, Global CMC Regulatory Affairs:

We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why.

We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:
Our approach to R&D

In this role you will be responsible for supporting the CMC regulatory activities relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations).

Responsible for the global CMC regulatory activities associated with devices for assigned projects and respond readily to changing events and priorities.
Works in crossfunctional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy for devices.
Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
Ensures regulatory compliance is maintained and shares bestpractices and learnings within the CMC Regulatory teams and other impacted functions.
Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency) and potentially external advocacy and shaping the regulatory environment).
Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

_ Closing Date for Applications: 31/01/2023_
Please take a copy of the Job Description, as this will not be available post closure of the advert

_ Why you?_:

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

BSC Life sciences or related scientific discipline. To ensure a good understanding of the science behind physical device development and the associated regulatory challenges
Device regulatory affairs or device (standalone and in all types of drugdevice combinations) development and manufacturing experience with direct involvement in regulatory submission preparation for devices.
Sound knowledge of device development, manufacturing processes and supply chain.
Knowledge of worldwide CMC regulatory requirements for devices and successful track record of delivering dossiers that comply with these
Good time management skills with the ability to effectively plan, prioritise and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

Masters degree Life sciences or related scientific discipline Regulatory Affairs Certification (RAPS)
Development experience ideally including previous roles within product development.
Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
Experience influencing and negotiating with company personnel, regulatory agencies, and industry bodies in a variety of settings.
Strong interpersonal, presentation and communication skills with established internal networks.

Demonstrated ability to handle global CMC issues related to devices through continuous change and improvement.

_ 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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.