Regulatory Affairs, Project Management, Process Excellence and Quality, Lean Six Sigma

6/2015 – 1/2020

• Compilation, review and regulatory submission (MAA, renewals, variations) in EU and other international markets
• Respond to deficiency letter from health authorities
• Creation and maintenance of submission plans
• Coordinate with local experts to obtain Regulatory Intelligence for clients
• Responsible for maintenance of registration databases
• Coordinate with project teams for Risk Management
• Plan regulatory project forecast and budget
• Conduct root cause analysis and determine CAPA for RA Quality Issues
• Prepare and effectively manage project teams for client audits and regulatory inspections
• Develop Quality Control process for RA activities based on client KPI
• Develop and update written standard methodologies for regulatory deliverables

Regulatory Affairs, Projektmanagement, Six sigma, Total-Quality-Management

2/2012 – 5/2020

• Preparation, review and submission of regulatory documents (CTD Modules 1, 2 and 3) for world wide registrations
• Handling of regulatory deficiencies and product CMC life cycle management
• Liaison with other departments for project management
• Coordination for manufacturing license applications
• Notification of the changes to regulatory authorities and customers
• Review documentation of quality management system

Regulatory Affairs

10/2008 – 1/2012

• Preparation, submission and review of DMF in conformance with the regulatory requirement for US, Europe, Canada and ROW in eCTD, paper submission, NeeS format, Single PDF
• Liaison with other departments for submission /deficiencies documents
• Review of Change Controls and Deviations
• Support regulatory inspections (USFDA, MHRA, KFDA)
• Review customer agreement in coordination with legal department
• Deliver training sessions on regulatory submission requirements
• Involved in organisational improvement projects - Lean Six Sigma, Yield improvement analysis, Cp, Cpk calculation and value stream mapping

Regulatory Affairs, Projektmanagement - Audits, Six sigma, Total-Quality-Management