One of our biggest clients in Basel is looking for Regulatory Affairs Regional Coordinator to provide operational support to Regulatory Affairs (RA) Regions. You will be responsible for organization and coordination of business critical documents, required for regulatory submissions in Rest of the world countries.
Tasks & Responsibilities:
Support regulatory activities (New Marketing Authorization Applications, line extensions, renewals, CMC changes, Safety Label Changes) in Rest of World countries, by ensuring timely and accurate availability of business-critical documents, not provided as part of the core dossier
Manage and coordinate process for Apostille or legalization of business critical documents required to support regulatory activities in Rest of World countries
Manage relationship to external vendors providing legalization and notary services – act as Single Point of Contact with these vendors
Manage and coordinate process for Letters of Authorization, required by Health Authorities to support regulatory activities in Rest of World countries
Coordinate and facilitate timely delivery of business critical documents to Country Organization worldwide
Manage tracking of all legalization and dispatch activities, ensuring accurate and timely oversight available to relevant business partners
Provide operational support to RA Regions, e.g. maintaining generic mailbox, maintaining archive, organizing meeting support, coordination of signatures
Provide training on declaration letters and legalization process to RA Regions and key stakeholders as needed
Manage and supervise on the RAD request tool, as well as participate in yearly system testing
Requirements:
• Commercial training (e.g. Swiss Association of Commercial Employees, business school) or equivalent (e.g. other vocational qualification) or bachelor’s degree
• Experience in Operational support role and relevant additional career training
• Good communication and negotiation skills
• Very good written and spoken English and knowledge of other languages (e.g. German, French) an advantage
Duration: Until 31/12/2025
Location: Basel, Switzerland
Start date: ASAP
Job Title: Regulatory Affairs Coordinator
Location: Basel, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield
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