Jobs at KMR Search Group

Lead design, implementation, and continual improvement of a pharmaceutical quality assurance function and quality management system. Oversee SOPs, document control, batch record review, deviations, change control, CAPA, internal and vendor audits, regulatory submission support, and quality IT (e.g., Veeva). Manage quality training, vendor programs, inspections, and quality metrics to ensure regulatory compliance and product development readiness.

Lead design, implementation, and continuous improvement of a Quality Management System supporting clinical development and regulatory approval. Oversee SOPs, document control, batch record review, deviation/change control, CAPA, audits, vendor management, regulatory submission support, and inspection readiness while managing a quality team and cross-functional quality activities.

Lead regulatory strategy and submissions (primarily CMC, also clinical and non-clinical) for investigational and marketed products. Serve as RA lead on cross-functional teams, liaise with FDA and other health authorities, drive regulatory due diligence, and implement policies to ensure timely approvals and compliance with ICH, FDA, and EU guidelines.

Lead global clinical regulatory activities including strategy and operations for IND/CTA and BLA submissions, liaison with FDA and other health authorities, and support clinical and marketing objectives to ensure compliance and timely approvals.

Provide global pharmacovigilance and safety leadership for immunology/inflammation products, including signal detection, risk/benefit assessment, safety strategy, regulatory submissions, cross-functional team leadership, and preparation of periodic safety reports and labeling input.

Lead design, implementation and continuous improvement of a Quality Assurance function and Quality Management System for clinical development and regulatory submissions. Own SOPs, document control, batch record review, deviation/change control, CAPA, audits, vendor quality, regulatory inspection readiness, and quality oversight of IT systems (e.g., Veeva). Collaborate with cross-functional teams and drive regulatory compliance (FDA/EMA/ICH/GMP) and quality metrics.