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Zuletzt aktualisiert: vor 9 Tagen
Regulatory Affairs Specialist - Mendrisio site (Ticino)

Regulatory Affairs Specialist - Mendrisio site (Ticino)

SinteticaMendrisio, Ticino, CH
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 benefi...Mehr anzeigenZuletzt aktualisiert: vor 28 Tagen
Junior medical affairs specialist

Junior medical affairs specialist

W&W Logo ColoreSvizzera, Ticino, Lugano
For an international organisation in the scientific and medical sector, we are looking for a.Junior Medical Affairs Specialist. The role focuses on providing administrative and operational support t...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Project Manager

Project Manager

Randstad (Schweiz) AGMezzovico TI
Randstad Inhouse Services (RIS) is an idea created to support companies with a high demand for flexible staffing.It aims to optimize labor flexibility, productivity and efficiency.For our client, J...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
Handler Part-Time

Handler Part-Time

FedExLugano, Ticino, Switzerland
CHJ FedEx Express Swiss Post GmbH.We have an exciting opportunity for you to join our Operations team as a package handler. FedEx is the largest express transportation company in the world connectin...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
JUNIOR MEDICAL AFFAIRS SPECIALIST

JUNIOR MEDICAL AFFAIRS SPECIALIST

Work & Work SALugano, Ticino, Svizzera
Quick Apply
For an international organisation in the scientific and medical sector, we are looking for a.Junior Medical Affairs Specialist. The role focuses on providing administrative and operational support t...Mehr anzeigenZuletzt aktualisiert: vor 9 Tagen
  • Gesponsert
Events Director

Events Director

Manpower SwitzerlandLugano
Established in 1948 in Milwaukee, Wisconsin (USA), Manpower is a global leader in the human resources industry.Operating in 82 countries with a network of over 3,900 offices, the company supports t...Mehr anzeigenZuletzt aktualisiert: vor 12 Tagen
Expediter

Expediter

Casale SALugano, TI, CH
Casale SA is a leading firm that specializes in the design and implementation of innovative plants to produce green ammonia, ammonia, nitrates, phosphates, urea, methanol, melamine, and syngas.With...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
HR Manager

HR Manager

ReleWantMendrisio, Ticino, Switzerland
Relewant è una società specializzata in ambito informatico che opera a livello nazionale e internazionale.La nostra mission è quella di connettere i migliori talenti con aziende allavanguardia crea...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Project Manager

Project Manager

RandstadMezzovico TI
Randstad Inhouse Services (RIS) is an idea created to support companies with a high demand for flexible staffing.It aims to optimize labor flexibility, productivity and efficiency.For our client, J...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
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Regulatory Affairs Specialist - Mendrisio site (Ticino)

Regulatory Affairs Specialist - Mendrisio site (Ticino)

SinteticaMendrisio, Ticino, CH
Vor 28 Tagen
Stellenbeschreibung

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

  • Master’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.
  • Preference will be given to candidates of Swiss nationality and residents (Permit B -C)

    We offer

  • Fulltime permanent employment in a young working environment and positive culture.
  • Sintetica promotes diversity and gender equality.