Supervisor logistics Jobs in Lugano
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Supervisor logistics • lugano
Regulatory Affairs Specialist - Mendrisio site (Ticino)
SinteticaMendrisio, Ticino, CHJunior medical affairs specialist
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Regulatory Affairs Specialist - Mendrisio site (Ticino)
SinteticaMendrisio, Ticino, CHFounded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
To strengthen our Regulatory Affairs department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Regulatory Affairs Specialist.
Position Summary
We are seeking a Regulatory Affairs Specialist to support regulatory compliance and contribute to the submission and maintenance of national and international authorizations. The role will operate under the guidance of a supervisor and will involve collaboration with cross-functional teams to ensure timely and accurate regulatory deliverables.
Key Responsibilities
- Support the preparation, submission, and maintenance of medicinal product registrations across global markets (EU, Switzerland, and Rest of World).
- Independently and critically prepare and / or review regulatory documentation for marketing authorization applications (MAAs), variations, renewals, and other regulatory activities.
- Coordinate with internal departments, local partners, Marketing Authorization Holders (MAHs), and external consultants to ensure high-quality submissions.
- Review product labeling to ensure compliance with applicable global regulatory requirements.
- Maintain registration documentation in alignment with the latest regulatory guidelines and health authority expectations.
Qualifications and Skills
Preference will be given to candidates of Swiss nationality and residents (Permit B -C)
We offer