Regulatory Associate

About the Job

The Regulatory Associate will report to the Regulatory Manager and will be responsible for managing products under development and/or marketed products

Roles and Responsibilities

• According to the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products
• Interface with various project/product teams. /
• Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
• Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
• Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate together with Business Unit Regulatory Manager.
• Manage the maintenance of a portfolio of products.
• Provide support and communicating information on products to other functions (approvals, ...).
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
• In liaison with his/her manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, recall etc.
• Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

Main Requirements

• Degree in medicine, pharmacy, chemistry sciences or other relevant life sciences
• Minimum 3-6 years’ experiencein similar positionin different types of registrations, preferably in multinational organization
• Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams

Skills

• Negotiation & communication skills
• Organization skills and high accuracy in documentation
• Knowledge of new decrees & guidelines
• Multitasker
• Promptness in respond to authorities requirements and prompt in deliverables / Otoritelerin gerekliliklerine anında cevap verme ve hızlı teslim
• Problem solving and interpersonal skills