Responsible Specialist FvP 60 - 80% (m/f/d)

What is my role?

In this important position, you assume the legal responsibility as FvP. You independently manage and lead customer projects – from planning to completion, always keeping an eye on quality, deadlines, and budget. You create, review, and finalise approval dossiers, handle new submissions, variations, renewals, and life-cycle management in the eCTD/eDOK formats. You maintain regular communication with Swissmedic. Additionally, you manage and review quality management systems, create and revise SOPs, evaluate PQRs, and conduct or support audits, self-inspections, and regulatory inspections.

What do I need to be successful?

For this challenging role, you require a university degree in pharmacy, natural sciences, or an equivalent qualification. Furthermore, you bring solid professional experience in the pharmaceutical environment with practical experience in Quality Assurance, Pharmacovigilance, and Regulatory Affairs. Ideally, you have experience as FvP or PVvP or the willingness to take the next step from a deputy role to FvP and/or PVvP. Besides confident German language skills, you also need very good English skills. We are looking for an open, positive personality who enjoys collegial collaboration and has a structured and precise working style. Regular on-site presence is important. Living near Richterswil on Lake Zurich is advantageous.

What are my benefits?

• Sustainable, interesting industry

• Responsible, varied tasks

• Motivated, collegial team

• Modern infrastructure

• Flexible working hours

• Attractive employment conditions with excellent social benefits

• Free parking spaces

What distinguishes the company?

Our client is an established pharmaceutical service provider with expertise in Regulatory Affairs, Quality Assurance, and Pharmacovigilance as well as in the fields of pharmaceuticals, foodstuffs, cosmetics, and medical devices.

Languages
German: C2 - Native level
English: B2 - Very good

Work location
Zurich Lake region / Richterswil

Vacancy number
VA-NPQ-D3J