Deep expertise in global combination product regulations
Experience leading combination product strategies and submissions
Solid understanding of drug and device development processes
The role involves providing strategic leadership for combination products across development, licensure, and post-marketing management to ensure successful approvals in key markets
Job Summary
The role involves providing strategic leadership for combination products across development, licensure, and post-marketing management to ensure successful approvals in key markets.
Candidates must possess deep expertise in global combination product regulations including FDA 21 CFR Part 4, EU MDR, and ISO standards.
The position requires leading regulatory interactions with global Health Authorities and authoring technical documentation for device-specific sections of regulatory dossiers.
Matching Summary
The role involves providing strategic leadership for combination products across development, licensure, and post-marketing management to ensure successful approvals in key markets.
Skills & Requirements
Must-have
Deep expertise in global combination product regulations
Experience leading combination product strategies and submissions
Solid understanding of drug and device development processes
Proven leadership skills in cross-functional team environments
Strategic mindset to drive execution in complex regulatory landscape
Nice-to-have
Strong influencing and stakeholder management skills
Continuous improvement mindset
Ability to work across cultural lines
Experience mentoring regulatory professionals
Key Requirements
Master degree or PhD in biotechnology, pharmaceutical sciences, or biological science
Experience in pharmaceutical/biotechnology industry with CMC and Device expertise
Leadership experience in Regulatory CMC for Device area and combination products