Senior Manager, Regulatory and PV Delivery
Core
Senior Manager providing franchise liaison between Ergomed Group and clients, managing complex regulatory projects, and securing new business.
Role type
Senior Manager, Regulatory and PV Delivery
Builds
Global pharmacovigilance and regulatory programs for pharmaceutical clients
Domain
Pharmaceutical industry / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Global project management, strategic regulatory guidance, training and mentoring, change management, audit readiness support, business development support, complex problem solving
Preferred skills
Post-marketing regulatory activities, lifecycle management
Technologies
ICH GCP, GVP, local legislation frameworks
Responsibilities
Lead and coordinate execution of high-complexity regulatory tasks; Provide strategic input and risk mitigation to internal/external customers; Act as franchise liaison between Ergomed Group and clients; Provide expert advice on complex regulatory queries; Assist in securing new business via BDM participation and proposal development; Foster professional relationships with internal and external contacts; Provide training, coaching, and mentoring to junior staff; Support client qualification and audit readiness; Drive department initiatives and manage change implementation