At a Glance
- Tasks: Ensure regulatory compliance for pharmaceutical products and support quality assurance across the site.
- Company: Join GSK, a leading global healthcare company with a commitment to innovation.
- Benefits: Competitive salary, annual bonus, training opportunities, and healthcare programmes.
- Other info: Dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in the pharmaceutical industry while developing your career.
- Qualifications: Relevant qualifications in science or engineering and experience in regulatory compliance.
The predicted salary is between 40000 - 50000 £ per year.
As (Regulatory) Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by the interpretation of corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site).
Key Responsibilities
- Act as product regulatory specialist for the site: Provide product regulatory advice for the impact of all changes made on site ensuring regulatory compliance in all markets.
- Maintain product quality specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements.
- Provide and approve regulatory information for periodic product reviews.
- Lead NPI submissions and reviews working with site SMEs and central/local functions to meet GSK submission & launch dates and without undue regulatory restriction on company operations.
- Ensure robust evaluation of registered detail that will be submitted to allow future operational flexibility and ensure compliance.
- Act as the primary site contact with central regulatory groups (pre and post approval) and Local Operating Companies (LOCs), making decisions on behalf of the site.
- Develop regulatory strategies using innovative thinking to support site and business strategies/priorities (NPI & existing products – line extensions), approving plans for wave 3 launches.
- Review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports) to meet GSK submission & launch dates and without undue regulatory restriction on company operations.
- Support regulatory compliance on site: Internal and external audits; Regulatory/Pharmacopoeial Intelligence; Provide support to maintain statutory Site licenses; Lead or assist with quality and compliance‑related deviations; Environment, Health and Safety (EHS) requirements.
About You
As this role is multi‑faceted and includes liaising with a wide variety of on‑site production and operations teams, you will be a self‑motivated person who has experience of working in regulatory, quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.
Basic Qualifications
- Relevant qualifications (e.g. HND or “A” levels in scientific, technical engineering discipline) and/or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry.
- Experience of managing regulatory compliance or regulatory affairs‑processes related activities within a pharma or consumer supply chain environment.
- Knowledge of current Good Manufacturing Practice (cGMP) requirements.
- Experience obtained working in highly regulated industry, including knowledge and application of the principle of the Quality Management Systems (QMS).
Preferred Qualifications
- Experience in regulatory affairs, particularly post‑approval licence maintenance and variation submissions.
Benefits
- Competitive base salary.
- Annual bonus based on company performance.
- Opportunities to partake in on‑the‑job training courses.
- Opportunities to attend and partake in industry conferences.
- Opportunities for support for professional development/chartership.
- Access to healthcare and wellbeing programmes.
- Employee recognition programmes.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Medicines at Ware are presented as either respiratory devices or in oral solid dose form, and the site has circa 1,500 highly motivated and capable people working there. The Ware site holds a unique position in our network as the site responsible for launching the company’s pipeline of new medicines in oral and solid dose forms, as well as operating a high‑volume commercial production for respiratory devices.
Conformance Specialist in Ware employer: GlaxoSmithKline
GSK is an exceptional employer, offering a dynamic work environment at our Ware manufacturing site, where you will play a crucial role in ensuring regulatory compliance for innovative medicines. With a strong focus on employee development, competitive benefits including annual bonuses and healthcare programmes, and a culture that values continuous improvement and collaboration, GSK provides a rewarding career path for Conformance Specialists looking to make a meaningful impact in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Conformance Specialist in Ware
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We think you need these skills to ace Conformance Specialist in Ware
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at GlaxoSmithKline!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show GlaxoSmithKline that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at GlaxoSmithKline!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At GlaxoSmithKline, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at GlaxoSmithKline
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at GlaxoSmithKline that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with GlaxoSmithKline’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
