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

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 Swissmedic Free Sales Certificates (FSCs) via the Swissmedic portal
• Manage notarizations and 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 related to a specific portfolio of products/projects
• Process invoices (Swissmedic, Notary, Consular Service, State/Federal Chancellery, etc.)
• Respond to inquiries from Swiss Regulatory authorities within strict timelines
• Identify and elevate key areas of regulatory risk
• Participate actively as a team member and provide regulatory advice to project teams
• Local support regarding audits and Quality and Regulatory meetings, including catering, room/restaurant reservations, hotel bookings, etc.
• 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:

• Strong knowledge of a regulatory, quality, or legal environment
• Previous administrative experience in a dynamic, fast-paced international environment
• Strong organizational skills and meticulous attention to detail
• Excellent team player who is proactive in making suggestions and generating ideas
• Ability to work with speed and accuracy to meet strict deadlines
• Networking expertise with worldwide senior executive assistants to manage complex agendas
• Time flexibility to handle worldwide time zone agendas
• Genuine interest and curiosity about overall functions to understand roles and responsibilities of critical stakeholders
• Tech-savvy to support global virtual working and telepresence/video conferencing tools
• Very good knowledge of MS Office applications (Excel, Word, PowerPoint) and effective use of travel and expense management tools
• Strong proficiency with remote meeting tools (Zoom, MS Teams, Webex, etc.)
• Proficient 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: Diversity Charter

Have We Sparked Your Interest?

If you find this role appealing, can thrive in a fast-paced working environment, and are passionate about fostering a culture of learning and growth, then we’d love to talk to you. Apply online using the form below.

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

Baxter is committed to supporting the need 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 enhances the benefits of connecting and collaborating in person in support of our mission.

Note: Only applications matching the job profile will be considered.