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- Tasks: Manage regulatory projects for innovative medical devices and drug-device combinations.
- Company: Join GSK, a leader in healthcare innovation with a mission to improve lives.
- Benefits: Enjoy competitive salary, bonuses, healthcare, and flexible hybrid working options.
- Why this job: Make a real impact on global health while developing your career in a supportive environment.
- Qualifications: Bachelor's degree in pharmacy, chemistry, or related field; experience in regulatory affairs preferred.
- Other info: Be part of a diverse team committed to patient care and scientific advancement.
The predicted salary is between 36000 - 60000 £ per year.
You will manage CMC (Chemistry, Manufacturing and Controls) regulatory projects for a portfolio of devices (standalone and all types of drug-device combinations). You will work closely with colleagues across supply, technical, quality and local operating companies. We value clear thinkers who build strong relationships, solve problems and keep patients' needs at the centre. This role offers visible impact, development opportunities and the chance to contribute to GSK's mission of uniting science, technology and talent to get ahead of disease together.
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.
In this role you will:
- Lead CMC regulatory activities for an assigned portfolio of devices (standalone and all types of drug-device combinations) across global markets.
- Develop and implement CMC regulatory strategies and plans (with managerial support) for lifecycle management and change control.
- Prepare variation dossiers and lead responses to questions from regulatory authorities.
- Coordinate and facilitate cross-functional CMC Regulatory Matrix teams and represent CMC in wider project teams.
- Ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams and other impacted functions.
- Deliver CMC regulatory strategy to support major inspections (PAIs) with managerial support.
Why you?
Basic Qualifications & Skills:
- Bachelor's degree or equivalent in pharmacy, chemistry or a related scientific discipline.
- Experience in device related (standalone or all types of drug-device combinations) regulatory affairs or device development or manufacturing.
- Direct involvement in preparing regulatory submissions for device aspects.
- Practical understanding of manufacturing processes, control strategies and supply chain.
- Knowledge of global CMC regulatory requirements for device aspects and a track record of delivering compliant dossiers.
- Strong time management with the ability to prioritise and coordinate multiple activities to meet deadlines.
Preferred Qualifications & Skills:
- Master's in pharmacy, chemistry or a related scientific discipline.
- Professional regulatory affairs certification.
- Experience influencing cross-functional teams and engaging with regulatory authorities.
- Proven track record of developing global regulatory strategies affecting supply and product plans.
- Strong written and verbal communication skills with experience presenting to diverse stakeholders.
- Experience leading process improvement or change initiatives in regulatory or manufacturing settings.
Closing Date for Applications – 29th of January 2026 (COB)
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.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
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.
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 at UKRecruitment.Adjustments@gsk.com where you can also request a call.
Regulatory Project Manager - Devices in London employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Project Manager - Devices in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, or even reach out to folks on LinkedIn. Building relationships can open doors that you didn’t even know existed.
✨Ace the Interview
Prepare for your interviews by researching the company and practising common questions. Think about how your experience aligns with their needs, especially in CMC regulatory activities. Show them you’re not just a fit, but the perfect fit!
✨Follow Up
After an interview, don’t forget to send a thank-you email! It’s a great way to express your appreciation and reiterate your interest in the role. Plus, it keeps you fresh in their minds.
✨Apply Through Our Website
Make sure to apply through our website for the best chance at landing that Regulatory Project Manager role. We love seeing candidates who take the initiative to engage directly with us!
We think you need these skills to ace Regulatory Project Manager - Devices in London
Some tips for your application 🫡
Tailor Your Cover Letter: Make sure to customise your cover letter for the Regulatory Project Manager role. Highlight your experience in CMC regulatory activities and how it aligns with our mission at GSK. We want to see how you can contribute to our goals!
Showcase Relevant Experience: In your CV, focus on your direct involvement in preparing regulatory submissions for devices. We’re keen to see your practical understanding of manufacturing processes and how you've navigated global CMC regulatory requirements.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language to describe your skills and experiences. We appreciate strong written communication, so make sure your application reflects that.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, you’ll find all the info you need about life at GSK there!
How to prepare for a job interview at Gsk
✨Know Your CMC Inside Out
Make sure you brush up on your Chemistry, Manufacturing and Controls (CMC) knowledge. Understand the regulatory landscape for devices and drug-device combinations, as this will be crucial in demonstrating your expertise during the interview.
✨Showcase Your Cross-Functional Skills
Prepare examples of how you've successfully collaborated with different teams in previous roles. GSK values strong relationships, so be ready to discuss how you’ve influenced cross-functional teams and engaged with regulatory authorities.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills. Think of scenarios where you had to manage multiple priorities or navigate regulatory challenges, and be prepared to explain your thought process and outcomes.
✨Align with GSK's Mission
Familiarise yourself with GSK’s mission and values. Be ready to articulate how your personal goals align with their ambition to positively impact patient health, as this will show your commitment to their vision.
