using EMA software. Enjoy autonomy in a fully supportive and engaging team environment. Why This Opportunity Stands Out...
verification for commercial control strategies. Strong command of ICH (Q5E, Q6B, Q8-Q12), USP/EP, FDA/EMA expectations...
integrity, and regulatory expectations (FDA, EMA) for commercial biologics/vaccine manufacturing. Proven client-facing...
with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (i.e., IND, SRDs...
proficient with ModMed/EMA systems. Responsibilities: - Greet and check in patients with professionalism and compassion...
of clinical trial design, execution, and regulatory requirements (FDA, EMA, ICH-GCP). Proven track record of managing multi-site...
regulatory submissions and interactions (FDA/EMA/others) Experience designing clinical development plans and leading global... understanding of GCP, ICH, FDA/EMA requirements Sound clinical judgment and ability to make decisions with incomplete/ambiguous...
during FDA, EMA, and other global regulatory inspections. Partner with Quality Assurance, Regulatory Affairs, Pharmacovigilance...
, and effective CAPAs Compliance & Regulatory Affairs Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable...
, well-equipped clinics using EMA Collaborative practice model with experienced dermatologists, APPs and strong clinical...