GlaxoSmithKline LLC Devices Specialist, Global CMC Regulatory Affairs' in Collegeville, Pennsylvania
Reference #: 358530\ Site Name: UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence\ Posted Date: Jan 17 2023\ 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:
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.\ Responsible for CMC strategy development (with managerial support) and creation of CMC submission documents for devices from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and commercial lifecycle management activities in accordance with the applicable regulatory & scientific standards.\ Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combination) to expedite the submission, review and approval of global CMC applications.\ Works in cross-functional 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 best-practices and learnings within the CMC Regulatory teams and other impacted functions.\ Engages in CMC Subject Matter Expert activities internally (for increased compliance,harmonisationand 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.\ When applying for this role, please use the \'cover letter\' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Why you?Qualifications & Skills:\ We are looking for professionals with the e 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 drug-device 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 co-ordinate 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.\ May be identified as CMC Regulatory expert in a specific subject area.\ 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. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\ Find out more:
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\'re committed to being more proactive at all levels