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.
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 for Swissmedic, notary services, consular services, and state/federal chancellery.
Respond to inquiries from Swiss regulatory authorities within strict timelines.
Identify and elevate key areas of regulatory risk.
Actively participate as a team member, providing regulatory advice to project teams.
Offer local support regarding audits and quality and regulatory meetings, including catering, room/restaurant reservations, and hotel bookings.
Set up purchase orders for projects, workshops, catering, and office supplies.
Manage the archive (both digital and 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.
Handle local supplier management.
Your Profile:
Good knowledge of a regulatory, quality, and legal environment, with an awareness of its importance.
Previous administrative experience in a dynamic, fast-paced international environment.
Strong organizational skills and attention to detail.
Excellent teamwork abilities, proactive in making suggestions and generating ideas.
Capability 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 to understand roles and responsibilities of critical stakeholders.
Technologically savvy to support worldwide virtual working and telepresence/video conference tools.
Proficient in MS Office applications (Excel, Word, and PowerPoint), with effective use of tools for travel and expenses; strong knowledge of remote meeting tools (Zoom, MS Teams, Webex, etc.).
Excellent communication skills in both English and German (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.
Interested in Joining Us?
If you are excited about the opportunity to thrive in a fast-paced working environment and are passionate about working in a culture of learning and growth, we would love to hear from you. Apply online using the form below.
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 on-site per week. This policy fosters connections and collaboration in support of our mission.
Only applications matching the job profile will be considered.
Location : Glattpark (Opfikon) Country : Switzerland