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 inquiries 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 administrative 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 player, proactive in generating suggestions and ideas
Ability to execute tasks accurately and within strict timeframes
Networking skills with worldwide senior executive assistants to manage complex agendas
Time flexibility to accommodate worldwide time zone agendas
Interest and curiosity about overall functions supported to understand the roles and responsibilities of critical stakeholders
Tech-savvy with the ability to support global virtual working and telepresence/video conference tools
Very good knowledge of MS Office applications (Excel, Word, PowerPoint), effective use of tools for travel and expenses, strong knowledge of remote meeting tools (Zoom, MS Teams, Webex, etc.)
Excellent 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 Commitment
Have We Sparked Your Interest?
If you resonate with the above role, thrive in a fast-paced working environment, and are passionate about working in a culture of learning and growth, then we would love to talk to 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">.
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.
Location : Glattpark (Opfikon) Country : Switzerland