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Zuletzt aktualisiert: vor 9 Stunden
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Regulatory Affairs Specialist - Mendrisio site (Ticino)
SinteticaMendrisio, Ticino, CHVor 8 Tagen
StellenbeschreibungMaster’s degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Biology, or related field). Minimum of 4–5 years of experience in Regulatory Affairs within the pharmaceutical industry focused on finished medicinal products (small molecules) Solid understanding of pharmaceutical legislation and regulatory frameworks. Proven experience with EU registration procedures (MRP / DCP MAAs, variations, extensions, and renewals). Previous experience with non-EU registrations is an advantage. Strong organizational and planning skills. Ability to interpret and effectively communicate regulatory requirements. Proactive, detail-oriented, and capable of working independently. Strong interpersonal and team collaboration skills; able to manage deadlines effectively. Proficient written and verbal communication skills in English. Knowledge of French and / or German is considered a plus. High attention to detail and a commitment to quality. Previous experience with finished pharmaceutical medicinal products is mandatory. Applications limited to experience in medical devices, food supplements, cosmetics, or APIs will not be prioritized. Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.
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.
- 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