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 global regulatory and quality assurance strategy for a clinical-stage pharmaceutical company. Oversee FDA and international submissions, manage QA systems (SOPs, CAPA, document control, training), advise senior leadership on regulatory risk, and direct cross‑functional regulatory and quality activities to ensure compliance and timely approvals.

Lead and mentor scientists to design, validate, and transfer NGS assays and workflows for a novel sequencing platform. Perform hands-on molecular biology experiments, generate technical instrument requirements, analyze/interpret data, document results in ELNs, and collaborate with cross-functional teams to support development, verification/validation, and commercialization of clinical NGS applications.

Lead EU regulatory strategy and execution for inflammation and musculoskeletal development programs. Support clinical development and MAA activities, manage submissions and agency interactions (EMA and national agencies), monitor EU legislation, liaise with business partners and alliance teams, and act as the EU regulatory subject-matter resource to drive timely program progression and compliant product approvals.

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.

Design and develop antibody IVD reagents and associated assay protocols using flow cytometry. Establish SOPs, product specs, QC methods, and technical/process documentation. Mentor junior scientists, transfer processes to manufacturing and QC, and communicate scientific results to internal teams and external collaborators. Support regulatory technical writing for certification and compliance.

Lead global regulatory affairs for approved and pipeline products, overseeing strategy, regulatory operations, labeling, medical writing, INDs/clinical applications, agency interactions, team leadership, budget management, and cross‑functional coordination to ensure timely global submissions and regulatory approvals.

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.

Lead facility engineering, construction project management, HSE and environmental compliance across pharmaceutical sites. Ensure GMP metrology, maintenance harmonization, emergency response, permitting, budgets, performance metrics, and staff development to maintain compliant, safe cleanroom and warehouse operations.

Design, develop, and maintain front-end and back-end web applications, create servers, databases, and APIs, ensure responsiveness and cross-platform optimization, collaborate with designers, and manage projects from conception to delivery.

Lead regulatory strategy and interactions with FDA and other authorities for development programs. Manage preparation, review, and submission of INDs, BLAs/MAAs, CTAs, and related amendments; provide regulatory guidance to multidisciplinary teams; review clinical and nonclinical data and protocols; ensure submission completeness; supervise regulatory submission planning and staff.

Analyze large company datasets to generate business insights for product, sales, marketing and leadership. Build, validate and deploy predictive models and algorithms, design A/B testing frameworks, assess new data sources, create data architectures, and coordinate with cross-functional teams to implement and monitor model performance and outcomes.

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.

Design, build, and optimize scalable data pipelines and architectures using SQL and AWS big-data technologies. Assemble complex datasets, automate processes, enable analytics and stream processing, secure cross-region data, and support cross-functional stakeholders including data scientists and product teams.

Lead US regulatory strategy for cell therapy manufacturing: author and coordinate FDA submissions, manage GMP licensing and inspection readiness, harmonize global regulatory processes, support CMC and due diligence, maintain regulatory documentation systems, and provide regulatory training and QA/quality-system reviews.

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.

Lead global CMC regulatory strategy and preparation of eCTD submissions for investigational and commercial biologics. Provide regulatory guidance to project teams, interact with health authorities, monitor evolving CMC regulations, and manage a team of Regulatory Affairs directors and managers.

Lead technical strategy and operations for bioinformatics assay development and CLIA/IVD clinical diagnostics. Oversee algorithm and data analysis across development and production, establish CLIA bioinformatics procedures, partner cross-functionally, and mentor bioinformatics data scientists/engineers.

Support preparation, coordination, and review of domestic and international regulatory submissions and annual reports for drug/biologic programs. Ensure compliance with FDA/EMA/ICH guidelines, review promotional materials and clinical protocols, interact with agencies and vendors, assist with inspections and audits, update procedures, and manage regulatory tasks within project timelines and budgets.