Regulatory Affairs Manager

AMARIS — Lausanne
22.07. | Employee | 100%

Amaris is hiring a Regulatory Affairs Specialist for the Life Sciences department based in Switzerland.

Regulatory Affairs Specialist

As a consultant, you will be handling regulatory affairs in the pharmaceutical / medical systems field. In particular, you will be conducting one or more of the following activities:

  • Preparation of specific regulatory requests (request for clinical tests approval, temporary utilisation authorisation (ATU), import requests, etc.),
  • Filing, changes and renewal of MAAs, Drafting,
  • validation and distribution of texts relating to packaging items and to product information,
  • Drafting of procedures related to regulatory activity,
  • Control of promotional elements,
  • Drafting of CE marking documentation.

 

Your profil:

  • 3 years experience in regulatory aff airs
  • and in international approvals in
  • the fi elds of medical technology or
  • pharmaceuticals, experience in quality
  • management and / or product
  • development is an advantage
  • Knowledge of MDD 93/42/EEC (product
  • classifi cation, defi nition of applicable
  • standards, conformity assessment
  • procedures) and other relevant
  • regulations (e.g. the future MDR
  • 2017/745)
  • Experience in working in
  • interdisciplinary teams
  • Excellent MS-Offi ce knowledge,
  • experience in handling document
  • control and / or ERP systems (e.g. SAP)
  • is an advantage

French and English proficiency written
and spoken, additional languages
are an advantage

 

22.07.2020
Employee, 100%

Required minimum profile

  • Regulatory affairs
  • GXP
  • Pharmaceuticals

Contact

AMARIS

Chemin des Coquelicots 16

1214 Genève/Vernier

No recruitment agencies please

AMARIS

Chemin des Coquelicots 16Genève/Vernier

Industry

Consultancy

Labels (1)

Training Company
Training Company

AMARIS

Chemin des Coquelicots 16Genève/Vernier

Industry

Consultancy

Labels (1)

Training Company
Training Company
Salary

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