REGULATORY AFFAIRS SPECIALIST


12.08.2024

 

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

 

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