PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist/Project Coordinator to join our growing life sciences company. In this role, you will ensure global compliance with European and CH requirements throughout the product lifecycle, from development and approval to post-market maintenance.

Specific activities and responsibilities:

Significant experience in Swiss Regulatory Affairs and, ideally, coordinating workload and activity management.

Required education:

Degree in relevant life science discipline

Required experience :

5-8 years of relevant experience

Required technical skills:

Minimum 5 years experience in CH Regulatory Affairs (e.g. Product Life cycle management, new MAA, Orphan Drugs, Line extensions, Product Information updates, Artwork review)
Able to monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
Experienced in interaction with HA
Able to ensure compliance with:
all regulatory processes, in readiness for both internal and external audits.
the regulations of assigned Countries
client processes

skilled in the use of a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
Ability to keep activities and resources overview
Experience with training / mentoring junior members
Good grasp of financial aspect of BU activities
Carry out periodic reviews and activity monitoring for transmission to clients.
Monitor quality indicators.
Manage the drafting of quality provisions.
Ensure the follow-up of the CAPAs.

Required languages:

English (professional fluency) AND

Italian / German/ French (at least 1 out of 3); Other EU language are considered a plus

Additional experience and/or skills: