Senior Specialist in Regulatory Affairs (male/female)

Job Description

To strengthen our CQA & RA team, we are currently seeking a

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

based in Opfikon, Zurich.

Your Responsibilities:

• Order Swissmedic Free Sales Certificates (FSCs) via the Swissmedic portal
• Notarizations / Legalizations of Regulatory and Quality documentation and FSC certificates
• Organize sign-offs of Quality and Regulatory documentation
• Compile and submit Regulatory documents according to Regulatory requirements
• Support regulatory activities relating to a 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 reservations, hotel reservations, etc.) and further local administrative support
• Set up purchase orders for projects, workshops, catering, office supplies, etc.
• Manage the archive (digital/paper)
• Represent or lead Regulatory Affairs in small project teams
• Organize and actively participate in Quality and Regulatory meetings, team meetings, and events in Switzerland and 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, proactive in a team by making suggestions and generating ideas
• Speed & accuracy - ability to complete tasks accurately and within strict timeframes
• Networking skills with worldwide senior executive assistants to manage complex agendas
• Time flexibility to manage worldwide time zone agendas
• Interest and curiosity about overall functions supported to understand the roles and responsibilities of critical stakeholders and the ability 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 the above role resonates with you and you can thrive in a fast-paced working environment, we would love to hear from you. Apply online using the form below. Only applications matching the job profile will be considered.

For any questions, please feel free to contact Teresa Feilhuber at Show e-mailm">Show e-mail.

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.