Job SummaryThe Regulatory Affairs and Compliance specialist will provide regulatory guidance to the Commercial and Operations in accordance with applicable regional regulatory requirements and will support the implementation of these legal requirements to ensure that the company implements the necessary changes. The Specialist is contributing to the legal tracking, vigilance, interpretation and, in cooperation with other business groups, concluding on necessary actions with regards to the new and updated legislation affecting VWR products and advise CMP production to secure that compliant products are put on the market in Europe. Major job duties: Support the business to resolve daily regulatory queries and ability to advise and provide recommendations on regulatory matters Identify problems and update working methods in own role with the benefit of defined procedures. Will be responsible for all day-to-day regulatory affairs within the assigned role Provide guidance (regulatory & operational support) to local RA and production team Support the implementation of the legal requirements to ensure that the company implements the necessary changes in SAP and procedures. Identify and follow up on upcoming and updated European legislation addressing product Safety and market needs affecting products by utilizing tracking tools and network Draft and define, in cooperation with stakeholders, instructions with appropriate conformity actions for Business Interact with Portfolio Management and CMP production to secure compliant products are placed on the market Interact with Central Regulatory Affairs, Local Regulatory Affairs, Legal Department, European and local Quality Managers, Chief Scientist, Procurement, Sourcing, Central Planning, Logistics, Product Portfolio, Sales, Operations, Suppliers and Manufacturers marketing in compliance matters (e.g. requirements for new products, interpretation of regulations and standards, etc.) Act/report proactively when recognizing significant business risk for VWR. Escalation of issues to the RA leadership QUALIFICATIONS: (Education/Training, Experience and Certifications) B.S. or other relevant degree. 3 or more years’ experience in regulatory affairs in the European jurisdiction Comprehensive understanding of legal requirements Experience in Lab Supply Pharma / Chemicals or equivalent experience Proficiency in Microsoft Office tools and SAP (ERP) Fluent in English, at least one additional language would also be an advantage KNOWLEDGE SKILLS AND ABILITIES: (Those Necessary to Perform the Job Competently) Ability to collaborate in a multicultural environment Highly organized Need awareness, knowledge and interpretation skills for the various regulations and licensing in Europe and AMEA Able to make/drive decisions and take responsibility for outcomes Consistent exercise of independent judgement and discretion in matters of significance Knowledge of SAP processes and extended computer skills Adaptive, flexible, and change oriented Strong analytical and problem-solving skills Customer centric with advanced communication skills Ability to define solution driven actions Willing to travel as required Ideally experience in Product Compliance matters . We will use the personal information that you have submitted to us in order to consider your application for the relevant role. Your privacy is important to us. Please click here for our Privacy Policy which explains the purposes for which we will use your personal information and the ways in which we will handle and retain your information. It also explains the rights you have in relation to your information, and how to contact us with any queries or requests. 3rd party non-solicitation policy By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
Regulatory Affairs and Compliance specialist in Bucuresti
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