Regulatory Affairs Specialist - Mendrisio site (Ticino) — Sintetica SA

Role overview

Regulatory Affairs Specialist - Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI).

Regulatory Affairs Specialist - Mendrisio site (Ticino) Founded 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.