Regulatory Affairs Specialist

Regulatory Affairs Specialist selection

Position: RA Specialis

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 RA 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 RA 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 RA 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 dept. at hr@lagap.ch. Applications not in line with the requirements will not be followed up.

 

If interested, send your application to our HR dept. at hr@lagap.ch.

Applications not in line with the requirements will not be followed up.