To strengthen our CQA & RA team, we are currently seeking a:
Senior Specialist (f/m/d) Regulatory Affairs EMEA
Based in Opfikon, Zurich, you will play a key role in various regulatory activities. Your responsibilities include:
Ordering Swissmedic Free Sales Certificates (FSCs) via the Swissmedic portal.
Notarizations and legalizations of regulatory and quality documentation and FSC certificates.
Organizing sign-offs of quality and regulatory documentation.
Compiling and submitting regulatory documents according to legal requirements.
Supporting regulatory activities relating to a specific portfolio of products/projects.
Processing invoices (Swissmedic, Notary, Consular Service, State / Federal Chancellery, etc.).
Responding to inquiries from Swiss regulatory authorities while adhering to strict timelines.
Identifying and elevating key areas of regulatory risk.
Participating as an active team member and providing regulatory advice to project teams.
Offering local support regarding audits, quality and regulatory meetings, including catering, room/restaurant reservations, and hotel bookings.
Setting up purchase orders for projects, workshops, catering, office supplies, etc.
Managing the archive (both digital and paper).
Representing or leading regulatory affairs in small project teams.
Organizing and actively participating in quality and regulatory meetings, team meetings, and events within Switzerland and the EMEA region.
Managing local suppliers.
Your Profile
We are looking for candidates who possess:
A strong knowledge of a regulatory, quality, or legal environment and an understanding of its importance.
Previous administrative experience in a dynamic, fast-paced international environment.
Exceptional organizational skills and attention to detail.
The ability to work effectively within a team, demonstrating proactivity by making suggestions and generating ideas.
Speed and accuracy in completing tasks within strict deadlines.
A flexible approach to networking with senior executives to manage complex agendas.
A keen interest in understanding the functions supported and the roles of critical stakeholders.
Proficiency in using technology to enhance virtual working and video conferencing tools.
Strong knowledge of MS Office applications (Excel, Word, and PowerPoint) and experience with travel and expense tools; familiarity with 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 continually enhance your skills and knowledge. Additionally, 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 dedicated to promoting diversity as a true asset that enriches our organization: Diversity Commitment.
Have We Sparked Your Interest?
If you find this role intriguing and believe you can thrive in a fast-paced environment enriched by 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 flexibility in the workplace through our flexible workplace policy, which includes a minimum of three days a week onsite. This policy enhances the benefits of connecting and collaborating in-person in support of our mission.
Location : Glattpark (Opfikon) Country : Switzerland