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

CHF 66'500 - 110'500

Sintetica SA · Mendrisio (TI)

Categoria: pharma Contratto: other Salario: CHF 66'500 - 110'500

LohnCHF 66'500 - 110'500

Regulatory Affairs Specialist

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

We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them.

Regulatory Affairs Specialist
Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI). Regulatory Affairs Specialist
Key Responsibilities
Support the preparation, submission, and maintenance of medicinal product registrations across global markets (EU, Switzerland, and Rest of World).
and Skills
Master’s degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Biology, or related field).

Key Responsibilities
Support the preparation, submission, and maintenance of medicinal product registrations across global markets (EU, Switzerland, and Rest of World).

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.

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.

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.
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.

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.

Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI). Qualifications and Skills

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