Senior Manager GRA CMC Combination Product and Standalone Medical Device Specialist

About the role

Lead global CMC regulatory strategy for drug-device combination products and medical devices. Design and execute CMC regulatory plans, ensuring compliance with global requirements. Author and review high-quality regulatory submissions. Collaborate with R&D, quality, manufacturing, and clinical teams to integrate device and drug requirements. Manage change control processes and interact with health authorities worldwide. Monitor regulatory trends and shape internal best practices. Mentor junior staff and contribute to a collaborative, science-driven environment.

Responsibilities

• Lead global CMC regulatory strategy for drug-device combination products and medical devices.
• Design and execute CMC regulatory plans, ensuring compliance with global requirements.
• Author and review high-quality regulatory submissions.
• Collaborate with R&D, quality, manufacturing, and clinical teams to integrate device and drug requirements.
• Manage change control processes and interact with health authorities worldwide.
• Monitor regulatory trends and shape internal best practices.
• Mentor junior staff and contribute to a collaborative, science-driven environment.

Qualifications & Skills

• Expertise in CMC regulatory strategies for combination products and medical devices.
• Strong ability to develop and review regulatory documentation.
• Excellent collaboration, communication, and leadership skills.
• Knowledge of global regulatory requirements and trends.
• Ability to guide teams and influence best practices in regulatory affairs.