Regulatory Affairs Specialist

Main responsibilities:

• Manage regulatory projects of new submissions and life cycle management of Acino portfolio products in countries within the assigned region(s), apply with propositions
• Lead and supervise a small group of regulatory specialists/associates to support Strategic Regulatory Affairs for new submissions and life cycle management as per assignment, including onbording trainings and knowledge sharing
• Support of local partners in the region(s) in regards of Health Authority interactions in the assigned areas and countries (such as support with getting scientific advise, preparation of responses to deficiency letters or meetings) as per agreed responsibility level
• Management of timely and appropriate communication with regions regarding all planned variations of drug product, support in submission planning, preparation and monitoring of approvals

Requirements to the candidate

• High school, PTA, CTA, MTA, Bachelor degree , preferably in Pharmacy, Chemistry, Biology or another life science, plus several years of working experience in pharmaceutical area preferably in regulatory affairs
• Good knowledge of product life cycle, various international regulatory requirements and the registration procedures as well as understanding of the drug development, production process, pharmacovigilance and quality assurance topics
• Computer literacy (MS-office tools), good understanding of databases, portfolio tracking system (rita) and document management system (dB) and other applications and tools
• Good analytical, organizational and self-management skills and independent working style; Good communication, negotiation and interpersonal capabilities
• Ability to work cross-functionally and in international environment
• Target-oriented personality, able to work under pressure and on multiple tasks simultaneously
• Fluent in writing and negotiation in English. Know-how in further languages is of advantage