AddressPosted Date: Jun 24 2024
We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.
Regulatory Compliance Specialist
Closing Date for Applications - 15th July (COB)
This is a centrally based hybrid role in the External Quality Organisation
The Regulatory Compliance Specialist role will be responsible for key systems and processes for change and regulatory conformance and compliance within External Quality. The role will also develop, coordinate and provide an expert input into, regulatory strategies and compliance topics for the manufacture and registration of drug products and drug substances managed in external quality.
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 be:
- Responsible for advising on Regulatory Compliance and conformance by the interpretation of registered details such as RA1 as part of the change control assessment process, corporate standards, pharmacopoeial requirements, regulatory authority directives and commitments
- Proactively identify opportunities and strategies where complexity of regulatory filings can be reduced or simplified, to improve compliance and provide business benefit. (for example bundling of changes through the change control process)
- To provide consultancy on Regulatory Compliance and conformance topics
- To follow up on intelligence on new legislation and regulatory requirements and provide an expert interpretation of impact to the business, and actively communicate this to the relevant stakeholders.
- To manage and be accountable for the execution of the change control process and tools within External Quality including management of performance metrics, and linkages to Regulatory change control processes and systems (example RADAR), externalization of registered details to CMOs where appropriate, etc.
- Build relationships with other parts of the GSK business in order to drive excellence within the regulatory conformance and compliance space
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- University degree in science or engineering or equivalent experience
- Minimum 5 yrs experience in a Quality function within a highly regulated environment
- Excellent prioritisation skills and ability to work in a complex environment
- Ability to influence with or without authority at levels above and below own grade level.
- Ability to work within a team to identify novel solutions to specific process and systems related issues
- Demonstrated effective communication skills (both written and oral) coupled with the ability to tailor these to a variety of audiences.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Experience in change control processes and Regulatory Compliance processes
- Experience in the use of Veeva systems for applications of change control and regulatory documents
- Continuous improvement experience and/or certification
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 their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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