• Together with Business planning department develop a strategy of dossier submissions and approval time of initiated variations to provide uninterrupted supply of Company products to Russia&CIS; market
• Represent or lead the RA function on assigned cross-functional project teams of Russia&CIS; PCO and Global Company to solve arising technical or functional problems; timely provide of necessary information and support
• Guarantee of registration process carrying out in strong accordance with Russia&CIS; legislation and Company internal procedures.
• Establish and maintain relations with representatives of Regulatory State Agencies carrying out products expertise and registration strong accordance with Russia&CIS; legislation and Company internal procedures.
• Run business correspondence and negotiate with representatives of Regulatory State Agencies in context of registration process.
• Contact with manufacturing site’s representatives; direct inquiries and requirements of local Health Authorities to manufacturing site
• Store documents and information in strong accordance with Company internal procedures
• Review promotional materials for compliance with national regulations
• Support interaction with ASAPs for implementation of Field Corrective Actions
Требования к соискателям
от 1-2 лет
*Pharmaceutical and chemical knowledge
*Excellent analytical & problem solving skills
*Excellent oral and written communication
*Collaborative interpersonal skills to foster a team environment
*Ability to work independently under strict deadlines and changing priorities
*Able to multitask and prioritize changing workload on a daily basis
*In-depth knowledge of ICH guidelines & other worldwide and regional safety regulations
*Ability to establish priorities for self and others & proceed with objectives
*Experience with building relationships with regulatory agencies
*Critical requirements to experience