Senior Specialist (f/m/d) Regulatory Affairs EMEA

Job Description To strengthen our CQA & RA team, we’re currently seeking a

Senior Specialist (f/m/d) Regulatory Affairs EMEA

based in Opfikon, Zurich.

Your responsibilities:

Order of Swissmedic Free Sales Certificates (FSCs) via the Swissmedic portal Notarizations / Legalizations of Regulatory and Quality documentation and FSC certificates Organize signoffs of Quality and Regulatory documentation Compile and submit Regulatory documents according to Regulatory requirements Support regulatory activities relating to specific portfolio of products/projects Process invoices (Swissmedic, Notary, Consular Service, State / Federal Chancellery etc.) Respond to questions from Swiss Regulatory authorities within strict timelines Identify and elevate key areas of Regulatory risk Participate as an active team member and provide Regulatory advice to project teams Local support regarding audits, Quality and Regulatory meetings (catering, room/restaurant reservation, hotel reservations etc.) and further local admin support Set up purchase orders for projects, workshops, catering, office supplies etc. Management of the archive (digital / paper) Represent or lead Regulatory Affairs in small project teams Organization and active participation in Quality and Regulatory meetings, team meetings and events in Switzerland and in the EMEA region Local Supplier Management

Your Profile:

Good knowledge of a regulatory / quality / legal environment (awareness of importance) Previous administrative experience in a dynamic, fast paced international environment Strong organizational skills and attention to detail Excellent team worker, pro-active in a team by making suggestions and generating ideas Speed & accuracy - get tasks done accurately and within strict timeframes Networking with worldwide senior executive assistant to manage complex agenda Time flexibility to be able to manage worldwide time zone agendas Interested and curious about overall functions supported to understand role and responsibility of critical stakeholders and be able to filter meeting & contact requests Technology savvy to support worldwide virtual working and telepresence / video conference tools Very good knowledge of MS Office applications (Excel, Word and PowerPoint), effective use of tools for travel & expenses, strong knowledge of remote meeting tools (Zoom, MS Teams, Webex etc.). Very good communication skills in English and German (both written and spoken)

Our offer:

We provide professional development opportunities to help you continuously enhance your skills and knowledge. Alongside this, we offer competitive remuneration packages to recognize and reward your contributions.

We believe in fostering a diverse and inclusive work environment where individuals from all backgrounds can thrive. We are committed to promoting diversity and consider it a true asset that enriches our organization: https://www.charta-der-vielfalt.de/

Have we sparked your interest?

If you like the sound of the above role, can thrive in a fast-paced working environment and are passionate about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.

For any questions, please feel free to contact Teresa Feilhuber at teresa_feilhuber@baxter.com

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.