GlaxoSmithKline LLC Hiring for Devices Specialist, Global CMC Regulatory Affairs’ at Collegeville, Pennsylvania Full Time

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