Global Device CMC Regulatory Project Manager

GSK; Hertford; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A global healthcare company in Hertford is looking for a professional to manage CMC regulatory projects for a range of devices. You will lead regulatory activities, develop strategies, and ensure compliance, making a tangible impact on patient care. The ideal candidate has a degree in pharmacy or chemistry, regulatory affairs experience, strong communication skills, and the ability to work across teams. This position offers a hybrid model and a competitive salary with additional benefits.

Benefits

Competitive salary

Annual bonus based on performance

Healthcare and wellbeing programmes

Pension plan membership

Shares and savings programme

Qualifications

• Experience in regulatory affairs for devices or drug-device combinations.
• Direct involvement in preparing regulatory submissions.
• Knowledge of global CMC regulatory requirements.

Responsibilities

• Lead CMC regulatory activities for assigned devices.
• Develop regulatory strategies and plans for lifecycle management.
• Prepare variation dossiers and respond to regulatory authority questions.

Skills

Regulatory affairs

Project management

Cross-functional teamwork

Communication skills

Education

Bachelor’s degree in pharmacy, chemistry or related discipline

Job description

A global healthcare company in Hertford is looking for a professional to manage CMC regulatory projects for a range of devices. You will lead regulatory activities, develop strategies, and ensure compliance, making a tangible impact on patient care. The ideal candidate has a degree in pharmacy or chemistry, regulatory affairs experience, strong communication skills, and the ability to work across teams. This position offers a hybrid model and a competitive salary with additional benefits.