Senior Consultant Regulatory Supply Chain Compliance / Life Sciences (m/w/d)
Core
Advise Life Sciences clients on regulatory compliance and supply chain setups along the pharmaceutical value chain.
Role type
Senior Consultant Regulatory Supply Chain Compliance (Life Sciences)
Builds
Regulatory operating models, supply chain structures, and compliance processes for Pharma/Biotech/MedTech clients.
Domain
Life Sciences / Regulatory Affairs / Supply Chain
Deliverable
client delivery
Required skills
Regulatory analysis, Operating model design, Risk assessment, Project management, Gap analysis, GxP knowledge
Preferred skills
WDA/MIA experience, Quality Agreements, Responsible Person/Qualified Person responsibilities
Technologies
GMP, GDP, GxP
Responsibilities
Analyze and evaluate regulatory requirements in GMP/GDP/GxP environments; Develop and assess EU/international operating models including WDA and MIA; Conduct Gap Assessments, risk analyses, and compliance reviews; Lead work packages in consulting projects.
Seniority
Senior, hands-on IC