Regulatory CMC Manager, Devices

Role Summary

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.

Responsibilities

• 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

• Bachelor‚Äôs 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

• Advanced degree (Master‚Äôs 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 aseptic processing, device testing, human factor verification and validation, notified body opinions, and design control quality management systems.

Education

• Not specified beyond the required Bachelor‚Äôs degree; advanced degrees are preferred.