Global Regulatory Affairs Submission
As a seasoned regulatory affairs submission leader
I support the development, testing, manufacturing, and marketing of healthcare products to provide the safest, most effective, and highest-quality medical devices, pharmaceuticals, biologics, diagnostics, and digital health for patients and the public at large.
I play an essential role in ensuring that healthcare products get to market and stay on market with a keen eye on patient safety and quality of care. I am playing an integral part in strategic planning, helping companies through the myriad of international regulations. No successful market entry strategy can be established without an informed review of global regulatory considerations.
Key Competencies
Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development
Ability to interpret, discuss efficacy, and safety data relating to multiple therapeutic areas
Knowledge of regulatory agencies and best practices
Regulatory Strategy & Submissions
IND, NDA, BLA, ANDA, sNDA, MAA, CTA, variations, supplements
eCTD/CTD publishing & submissions management
Regulatory lifecycle management (labeling, CMC, post-marketing changes)
Health Authority Interactions
FDA, EMA, MHRA, PMDA, Health Canada engagement
Scientific Advice, Type B meetings, CHMP interactions
Regulatory intelligence & gap analysis
Compliance & Quality
ICH, FDA, EMA, GxP (GMP, GCP, GLP) compliance
Audit/inspection readiness & responses
SOP development & process improvement