Regulatory Affairs Specialist - Mendrisio site (Ticino) — Sintetica SA
CHF 66'500 - 110'500
Sintetica SA · Mendrisio (TI)
- Location
- Mendrisio
- Contract
- other
- Posted
- —
SalaryCHF 66'500 - 110'500
Role overview
Regulatory Affairs Specialist Mendrisio site (Ticino)
We collaborate closely with clinical experts to understand their needs and push the limits of science and technology to make therapies safer and easier to use.
With millions of doses supplied annually across various therapeutic classes, we are expanding to address further healthcare needs.
- Regulatory Affairs Specialist Mendrisio site (Ticino)
- We collaborate closely with clinical experts to understand their needs and push the limits of science and technology to make therapies safer and easier to use.
- We are seeking a Regulatory Affairs Specialist to strengthen our Regulatory Affairs department at our headquarters in Mendrisio (Switzerland).
- The role involves supporting regulatory compliance and contributing to the submission and maintenance of national and international authorizations, under the guidance of a supervisor and in collaboration with cross-functional teams.
- 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.
- Sintetica SA, Mendrisio (TI) Sintetica SA, founded in 1921 and headquartered in Mendrisio (Switzerland), is dedicated to continuously improving therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
Main responsibilities
- We are seeking a Regulatory Affairs Specialist to strengthen our Regulatory Affairs department at our headquarters in Mendrisio (Switzerland).
- The role involves supporting regulatory compliance and contributing to the submission and maintenance of national and international authorizations, under the guidance of a supervisor and in collaboration with cross-functional teams.
- 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.
Key requirements
- 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.
What the company offers
- Sintetica SA, Mendrisio (TI) Sintetica SA, founded in 1921 and headquartered in Mendrisio (Switzerland), is dedicated to continuously improving therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
- Cosa offriamo - Fulltime permanent employment in a young working environment and positive culture. - Sintetica promotes diversity and gender equality.
Application process
- 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)
Additional details
- Regulatory Affairs Specialist Mendrisio site (Ticino)
- Mansioni We are seeking a Regulatory Affairs Specialist to strengthen our Regulatory Affairs department at our headquarters in Mendrisio (Switzerland).
- 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.
Notes and original content
- Regulatory Affairs Specialist
- Mendrisio site (Ticino)
Questions about this listing
What salary does Sintetica SA offer for this role?
Sintetica SA lists CHF 66'500 - 110'500 gross per year for this position in Mendrisio. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Sintetica SA offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Sintetica SA during the application process, since these details can vary by role even within the same contract category.
Do I need the G permit to apply for this role in Ticino as an Italian cross-border worker?
Yes, if you are resident in Italy within the 20 km border zone. The Swiss employer files the G-permit application at the Ticino cantonal migration office after the contract is signed — first issuance takes 2-6 weeks, then automatic yearly renewal for as long as the employment continues. Weekly return to your Italian home is required to keep the status.
How do I apply for this position at Sintetica SA?
Use the "Apply now" button on this page — it links directly to Sintetica SA's original listing at app.ncoreplat.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
