Accomplished Regulatory Affairs executive with over 20 years of experience in the pharmaceutical/biotech industry. Leadership roles in global CMC, Quality, WW Regulatory Operations, leading global RA organization. Over 6 years of consulting supporting USA, EU, and global markets.
World-wide expert in leading global product registrations and strategy from clinical stages to the new product application and throughout the product lifecycle. Specialized in US and EU pharmaceutical law, BRIC and other Emerging Markets regulatory framework and cultural sensitivities. Fluent in Russian and Spanish.
Global GMP compliance gap assessment and inspection support including mock audits and translation services. Thorough understanding of GMPs, GLPs, GCPs and the requisite experience in resolving compliance issues in these areas.
Offer wide range of customized in-house training programs on US, EU and Emerging Markets pharmaceutical law, global GMP requirements, modern QMS design and implementation. Possess an engaging, unique, and interactive, training style with proven results and stellar feedback.
Established record of direct interactions and successful negotiations with FDA, USDA, HC, PMDA, MHRA, DVM, ANVISA, COFEPRIS, and other health authorities on compliance, regulatory strategy, and labeling areas. Experienced with diverse dosage forms, therapeutic groups, and route of administration.
Passionate advocate and active supporter of knowledge- and science-driven organization model that operate within the regulatory framework and result in an agile business model that benefits the patient and encourage Quality Culture environment. As a consultant, have an outstanding record providing compliance, training and regulatory support to a number of major pharma and biotech companies.
Specific Areas of Expertise Include:
- US and EU Pharmaceutical Law
- GMP requirements – global perspective and current updates
- Emerging Markets regulatory framework, cultural diversity, unique logistics
- CMC – new files and post approval changes
- Design of effective customized educational and training programs
- Established record of interaction and negotiation with Health Authorities
- Modern Quality System: design, implementation, continuous improvement, complete product life cycle management, quality culture elements
- Response to 483s, Warning Letters, regulatory compliance queries
- Preparation and management of NDA, BLA, MAA, IND, CTA
- Change Control system: design and management
- Data integrity: understanding and systemic prevention
- IRCA certified auditor