Regulatory Affairs Specialist / Project Coordinator – VAF 143

Groupe ProductLife; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A pharmaceutical company in Germany is seeking a motivated Regulatory Affairs Specialist/Project Coordinator. This role involves ensuring compliance with European and CH regulations throughout the product lifecycle. The ideal candidate should have extensive experience in Regulatory Affairs and excellent organizational skills. Proficiency in English is required along with knowledge of Italian, German, or French. Competitive salary and benefits are offered.

Qualifikationen

• At least 5 years of relevant experience in Regulatory Affairs.
• Experience in compliance with national and EU regulations.
• Professional fluency in English and at least one other EU language.

Aufgaben

• Ensure global compliance with European and CH requirements.
• Manage regulatory processes for clients.
• Conduct quality indicator monitoring.

Kenntnisse

Swiss Regulatory Affairs

Product Life Cycle Management

Microsoft Office Suite

Veeva Vault

Bilingual communication

Ausbildung

Degree in relevant life science discipline

Tools

LorenZ

Trackwise

PromoMat

Jobbeschreibung

Regulatory Affairs Specialist / Project Coordinator – VAF 143

Life Cycle

Regulatory Affairs & Operations

Permanent contract

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.

Responsibilities

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
• skilled in the use of a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data e.g. 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

• Previous experience of people management would be an advantage
• Good IT skills/knowledge
• Good organizational skills
• Good communication skills
• Pro-active attitude and able to work on own initiative as well as part of a team
• Ability to prioritize different workloads/multi-task
• Personal responsibility for ensuring a high standard of work