compliance analyst Irvine, Scotland
Job description
Posted Date: Jun 28 2023
Regulatory Compliance Specialist
GSK are recruiting a Regulatory Compliance to join on a part time secondment (Working hours will be 26.5hrs per week). The Regulatory Compliance role exists to deliver effective and efficient services in the areas of
Regulatory Compliance to the Irvine Site.
The Regulatory Compliance Specialist role will develop, or provide an expert input to, regulatory
strategies and compliance issues for the manufacture and registration of established drug
substances and Line Extensions. The role directs compliance by the interpretation of corporate
standards, pharmacopoeial requirements, regulatory authority directives and commitments made
to regulatory authorities relevant to Irvine, and other GSK companies or third party contractors or
customers.
Find out more:
Our approach to R&D
In this role you will
You will also be responsible for:
- To develop regulatory strategies and plans using innovative thinking to ensure all viable interpretations of the regulations have been explored, with input from R&D Global Regulatory Affairs (GRA) and the relevant site supply chains to meet stakeholders, GSK’s business needs and maintain regulatory compliance.
- To manage the registration detail relevant to the Irvine Site, and other GSK companies or third party contractors and customers so that regulatory approval is achieved to meetGSK submission & launch dates and without undue regulatory restriction of company operations.
- To influence management and staff in multi-disciplinary teams through effective negotiation and prioritization.
- To gather intelligence on new legislation and regulatory requirements and provide an expert interpretation of impact to the business, and actively communicate this to the Irvine Site.
- To provide a day-to-day regulatory advice service to the Irvine Site, to ensure that manufacture and supply is compliant with the registration detail in all markets supplied, including Canada, Europe, Japan and Rest of the World, e.g. Advise on appropriate strategy in Operations (Production, Warehouse, Shipping) or Laboratory areas to accommodate change, which may affect cGMP, the quality of the product/system and/or registered details.
- To input into the Site Change Control Processes by providing appropriate Regulatory advice and manage Regulatory change documentation to support this.
- To maintain regulatory submissions and conformance details. To deliver authorised statutory documentation, e.g. Annual Reports to regulatory authorities.
- Manage the implementation of registered commitments to ensure continuous compliance and success in global regulatory authority inspections (e.g. MHRA).
- Deliver training materials on Regulatory Compliance topics
- To deputise for the Third Party Quality Lead.
- To provide consultancy on quality issues to both internal customers within Pharma Supply and external customers e.g. Chemical Development, GRA, New Submissions.
- To carry out internal audits.
Closing Date for Applications: 12/07 (COB)
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.
- LI-GSK
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Degree or equivalent in a scientific field
- Several years general experience in quality assurance, quality control, pharmaceutical production, analytical testing, or regulatory compliance.
- Good problem solving and analytical reasoning skills
- Thorough understanding of GMP, safety and other GSK regulatory requirements.
- Understand the manufacturing and testing processes for drug substances and intermediates
- Well developed verbal, numeric and presentation skills
- Computer literacy, competent in Microsoft packages
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Expert knowledge gained over at least 3 years, of GSK regulatory processes, external worldwide regulatory expectations, guidance and directives.
- Knowledge of specialist IT systems for regulatory change management.
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:
Annual Report 2021
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 positively impact the health of 2.5 billion people by the end of 2030.
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 so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
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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