Regulatory Affairs Manager / Quality Manager 60 - 80% (m/f/d)

What is my role?

In this important position, you assume the legal responsibility as QPPV. You independently manage and lead customer projects - from planning to completion. You create, review, and finalise marketing authorisation dossiers, handle new submissions, variations, renewals, and life-cycle management in the eCTD/eDOK formats. In doing so, you maintain regular communication with Swissmedic. Additionally, you oversee 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 demanding 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 also have experience as a QPPV or deputy QPPV or the willingness to take the next step from a deputy role to QPPV and/or deputy QPPV.

What are my benefits?

• Sustainable, interesting industry

• Varied tasks

• Modern infrastructure

• Flexible working hours

• 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

Work location
Zurich Lake region / Wädenswil

Vacancy number
VA-KPU-6KY