Regulatory & AHJ Manager
Core
Develop, manage, and maintain strategic relationships with regulatory and inspection authorities to secure permits and approvals for a multi-billion-dollar greenfield pharmaceutical manufacturing project.
Role type
Senior project regulatory and AHJ coordination manager
Builds
Greenfield pharmaceutical manufacturing facilities
Domain
Life sciences / Pharmaceutical manufacturing / Construction / Regulatory compliance
Required skills
Regulatory compliance strategy, AHJ relationship management, permit lifecycle management, code compliance coordination, risk mitigation, stakeholder leadership, multi-jurisdictional coordination, project schedule alignment
Preferred skills
GMP-regulated facility experience, Owner's Representative or PMC background, environmental permitting expertise, commissioning and startup support in regulated environments
Technologies
EPC, EPCM, project delivery models
Responsibilities
Develop comprehensive regulatory compliance strategies; Serve as primary contact for Authorities Having Jurisdiction; Lead planning and submission of permits and approvals; Coordinate with engineering and design teams for code compliance; Identify and mitigate regulatory risks; Manage regulatory inspections and audits; Maintain regulatory documentation systems; Support CQV and startup activities; Provide leadership on regulatory obligations
Seniority
Senior, hands-on IC