Manager, Regulatory and PV Delivery
Core
Develop regulatory strategy and drive PV deliverables based on established plans, ensuring compliance and supporting new business acquisition.
Role type
Manager, Regulatory and Pharmacovigilance Delivery
Builds
Regulatory strategies, PV deliverables, proposals, and budgets for pharmaceutical clients
Domain
Pharmaceutical industry + Regulatory/Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Global project management, ICH GCP/GVP expertise, local legislation knowledge, strategic planning, risk management, budget monitoring, audit readiness, change management
Preferred skills
Line management experience, BDM participation, training and mentoring
Technologies
Regulatory databases, trackers, templates
Responsibilities
Lead complex regulatory projects and coordinate team execution; Provide strategic input and risk mitigation to internal/external customers; Advise clients on complex regulatory queries and local guidance changes; Monitor project budgets and escalate out-of-scope issues; Participate in BDMs and develop regulatory sections of proposals; Prepare invoices and review vendor invoices; Train, coach, and mentor junior staff; Support client qualification and audit readiness; Disseminate regulatory intelligence and impact analysis; Foster relationships with internal/external contacts; Drive department initiatives and manage change implementation
