Purpose: Accountable for local Regulatory activities ensuring compliance with Angelini global/local procedures and with national and international law/regulations for the products (pharma and non-pharma) registered and distributed in the Country. Provide regulatory strategic input to support commercial success of the Country Organization by increasing and maintaining products portfolio. Build and maintain strategic interactions with the Local Health Authorities to obtain the relevant approvals for regulatory applications (i.e., new MAAs, MA variations, MA renewals, certifications etc.). Ensure interaction and alignment with the Global RA team to support relevant priorities and objectives. Accountable for local Quality Management System oversight and compliance, in line with Global Angelini Pharma Quality Directives/Procedures and Country specific quality requirements Ensure compliance at the company level with national and international Pharmacovigilance (PV) and vigilance legislations/regulations. Implement the PV and vigilance strategy in the company, according to the guidelines received from Global Pharmacovigilance. Duties: Manage the regulatory strategy to maximize market potential. Support local and corporate business through: Regulatory input to the Country Manager, to the Country Organization and to the Global RA Global team Regulatory maintenance activities for the entire Angelini portfolio in the Country Secure regulatory submissions and approvals in line with business expectation and Global indications/timelines Build and maintain relationship with National Regulatory Authorities involved in regulatory affairs assessments to get the relevant regulatory approvals Build and maintain relationship with Trade Associations for regulatory activities Optimize operational strategy, planning, implementation, and information management ensuring regulatory/ethical compliance and timely/high quality submissions. Lead local team (Regulatory Manager, QA Specialist, PV Specialist). Manage local budget. Support Global PV in the fulfilment of Good Pharmacovigilance Practices (GVPs), Vigilance legal requirements and management of the Angelini PV/Vigilance System. Ensure local business continuity of the PV and vigilance systems. Requirements: - Experience in a similar role from 3 years - Experience in Pharmaceutical Company from 5 years - English language - advanced - People Management skills - Leadership skills
Адрес
Москва