R&D GRA CMC Team Lead
Core
Lead a specialist sub-team within the Global Regulatory Affairs CMC organization to oversee global regulatory strategies, risk assessments, and compliance for pharmaceutical products, biologics, and medical devices.
Role type
Senior IC regulatory strategy lead (CMC)
Builds
Global regulatory CMC strategies and risk assessments for development projects and marketed products
Domain
Pharmaceutical regulatory affairs / CMC
Deliverable
client delivery
Required skills
CMC regulatory strategy, drug development lifecycle knowledge, FDA/EMA regulatory navigation, matrix management, performance management, portfolio management, regulatory intelligence interpretation
Preferred skills
AI applications in regulatory affairs, strategic organizational change, advanced negotiation, stakeholder management, MS Office Suite, Veeva Vault, Plai
Responsibilities
Provide oversight and leadership of a specialist sub-team; oversee development of global regulatory CMC strategies and risk assessments; enable effective matrix management between line organization and project teams; interpret global regulations and implement them within the team's work; conduct regular performance evaluations and career development discussions; align team structure and capabilities with project portfolio needs
Seniority
Senior, hands-on IC with team leadership