Position: REGULATORY AFFAIRS SPECIALIST
Company: Lagap SA
Location: Vezia, Ticino, Switzerland
Contract type: full time, permanent
Education level: degree in scientific subjects or equivalent
Industry: Pharmaceutical
Lagap SA, a Swiss pharmaceutical company with over 50 years of international market presence, specializing in the primary and secondary production and packaging of oral solids, is seeking a REGULATORY AFFAIRS SPECIALIST to join its Regulatory Affairs team.
The Regulatory Affairs Specialist will manage pre-market Regulatory Affairs activities, supporting international registrations in the territories under their responsibility (mainly Switzerland and extra-EU Countries), in close coordination with Business Development and Regional Agents.
She/he deepens and monitors local regulatory requirements in the territories under her/his responsibility.
Responsibilities included, but not limited to:
- Planning activities, establishing tasks and prioritizing them es in coordination with Regulatory Affairs Manager.
- Supporting company’s partners (distributors and/or affiliates) in territories by collecting information and preparing required documents to obtain local registrations.
- Collaborating with QA and QC teams in developing new files relevant to meeting regulatory requirements.
- Maintaining regulatory databases, files and tools to ensure they are current and compliant with policies.
- Participating in project to improve RA processes.
Requirements:
- Master’s Degree in scientific, like Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry or Biology.
- At least 2-3 years of experience as Regulatory Affairs Officer in the pharmaceutical industry.
- Solid knowledge of relevant regulatory legislations.
- Strong attention to detail.
- Excellent communication skills, both verbal and written.
- Excellent data collection and analysis skills.
- Language: Italian, English, (CEFR B2/C1) - The knowledge of another European language and Arabic is a plus.
- IT skills: Proficiency in Office Suite and eCTD program.
We offer:
- Full time, regular contract (no home office).
- Competitive salary commensurate with the experience and qualifications.
- Dynamic work environment with continuous growth opportunities.
- Multicultural workplace.
If interested, send your application to our HR Department at [email protected]
Applications not in line with the requirements will not be followed up.
www.lagap.ch