Regulatory CMC Manager, Devices

GlaxoSmithKline; Ware; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A multinational pharmaceutical company is seeking a Regulatory CMC Manager for Devices to lead the development of regulatory strategies for medical devices. This role involves collaboration with various teams to ensure compliance and high quality in the design and lifecycle of products. Successful candidates will have a Bachelor's degree in engineering or life sciences and experience in regulatory affairs, along with strong communication and project management skills. The position offers a hybrid working model, based in Ware, England.

Qualifications

• Detailed experience in medical device and combination product development.
• Good knowledge of global medical device regulations and standards.
• Experience with risk management processes for medical devices.

Responsibilities

• Develop and implement regulatory device strategies.
• Collaborate with cross-functional teams to meet regulatory standards.
• Provide guidance on regulatory compliance and device design.

Skills

Project management

Collaboration

Communication skills

Problem-solving

Education

Bachelor’s degree in engineering, life sciences, or related field

Job description

Regulatory CMC Manager Devices

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.

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.

Qualifications & Skills:

• 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:

• 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

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.