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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.
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.
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.
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 where you can also request a call.
Regulatory Project Manager - Devices in Ware employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Project Manager - Devices in Ware
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at GSK or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for interviews by researching common questions for Regulatory Project Managers. Think about how your experience aligns with the role and be ready to share specific examples of your past successes.
✨Tip Number 3
Showcase your problem-solving skills during interviews. GSK values clear thinkers, so be prepared to discuss how you've tackled challenges in previous roles, especially in regulatory affairs or device development.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the GSK team.
We think you need these skills to ace Regulatory Project Manager - Devices in Ware
Some tips for your application 🫡
Tailor Your Cover Letter: Make sure to customise your cover letter for the Regulatory Project Manager role. Highlight your relevant experience in CMC regulatory projects and how it aligns with GSK's mission. We want to see how you can contribute to our goals!
Showcase Your Skills: In your CV, emphasise your skills related to device regulatory affairs and project management. Use specific examples that demonstrate your ability to manage multiple activities and meet deadlines. This is your chance to shine!
Be Clear and Concise: When writing your application, keep it clear and to the point. Avoid jargon and make sure your key achievements stand out. We appreciate straightforward communication that gets to the heart of your qualifications.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, you’ll find all the info about our company culture and benefits there too!
How to prepare for a job interview at Gsk
✨Know Your CMC Inside Out
Make sure you have a solid understanding of Chemistry, Manufacturing and Controls (CMC) regulatory processes. Brush up on the specifics of device-related regulations and be ready to discuss how your experience aligns with the role's requirements.
✨Showcase Your Cross-Functional Skills
This role involves working closely with various teams. Prepare examples of how you've successfully collaborated with cross-functional teams in the past. Highlight your ability to influence and engage with different stakeholders, as this will be key in your new position.
✨Prepare for Regulatory Questions
Expect questions about your experience with regulatory submissions and compliance. Be ready to discuss specific dossiers you've prepared and any challenges you've faced. This will demonstrate your practical knowledge and problem-solving skills.
✨Emphasise Your Time Management Skills
Given the fast-paced nature of regulatory projects, it's crucial to showcase your time management abilities. Prepare to discuss how you've prioritised tasks and coordinated multiple activities to meet tight deadlines in previous roles.
