This role involves guiding regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics
Job Summary
This role involves guiding regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics.
You will provide strategic regulatory guidance, lead submission preparations, interact with regulatory authorities, and manage regulatory intelligence activities.
The position offers the opportunity to make a significant impact on bringing innovative scientific solutions to market while ensuring compliance with evolving global regulations.
Matching Summary
This role involves guiding regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics.
Skills & Requirements
Must-have
Global regulatory compliance expertise
Regulatory submission experience (IND, BLA, NDA)
Cross-functional team leadership skills
FDA EMA PMDA NMPA knowledge
GMP QMS requirements understanding
Nice-to-have
Regulatory affairs certifications beneficial
Additional language proficiency
Strategic initiative leadership
Collaborative team environment
Innovative scientific solutions focus
Key Requirements
Advanced Degree plus 6 years experience or Bachelor's plus 8 years
Life Sciences, Chemistry, Engineering, Pharmacy background