Regulatory manager devices

Reference #: 428641

Site Name: UK - Hertfordshire - Ware RD, Durham Blackwell Street, GSK HQ, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Oct 13 2025

We are currently looking for a Regulatory CMC Manager Devices to join our team.

As Regulatory CMC Manager, Devices, you will play a key role in driving the development and delivery of global device-related regulatory strategies and solutions that support GSK's mission to get ahead of disease together. You will collaborate across multiple teams to ensure the successful design, development, and lifecycle management of medical devices and drug-device combinations, ensuring compliance with global regulatory requirements. This role offers the opportunity to make a meaningful impact, grow your expertise, and contribute to innovative solutions that improve patient outcomes.

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.

Find out more: Our approach to R&D

In this role you will:

Develop and implement regulatory device strategies to support product development, registration, and lifecycle management. Collaborate with cross-functional teams, including technical, regulatory, manufacturing, clinical and quality, to ensure device-related deliverables meet global standards. Provide interpretation and advice on regulatory guidance on device design, development, and compliance. Identify and manage device-related regulatory risks and develop mitigation strategies and communication to ensure project submission success. Support major inspections and audits related to device development and manufacturing from a regulatory strategy perspective. Proactively look to continuously improve processes and systems to enhance efficiency and quality in device-related regulatory activities.

Why you?

Qualifications & Skills: We are looking for a professional with these required skills to achieve our goals: Bachelor's degree (or equivalent) in engineering, life sciences, or a related field. Detailed experience in medical device and combination product development, manufacturing, or regulatory affairs. Good knowledge of global medical device regulations and standards. Strong project management and organizational skills. Ability to collaborate effectively in cross-functional teams. Excellent communication and problem-solving skills.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus: Advanced degree (Master's or PhD or equivalent) in engineering, life sciences, or a related field. Development experience ideally including previous roles within drug-device combination or vaccine products. Competent with risk management processes for medical devices. Experience working with external partners or suppliers. Proven ability to lead and mentor teams. Knowledge of emerging trends and technologies in medical devices and combination products. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Appreciation of some or all of the following would be desirable; aseptic processing, device testing, human factor verification and validation, notified body opinions, and design control quality management systems.

This role can be based in either the United Kingdom (Ware, London, Stevenage) or United states (Durham Blackwell street or Upper Providence) and follows a hybrid working model, offering flexibility between remote and in-office work.

We encourage you to apply if you are passionate about making a difference and have the skills and experience to thrive in this role. Join us in our mission to improve lives and get ahead of disease together.

Closing Date for Applications: 27th October 2025

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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 on [email protected] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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