Regulatory Affairs Associate – LCM (m/w/d)

Industry: Pharma
Skills: Business Administration, Regulatory Affairs Pharma

Start of project: 03.02.2023

Duration of the project : 6 Months

Project volume: 160 Month(s) 

Location: St Gallen

Responsibilities:

• Maintenance of GMP certificates repository, in co-operation with Quality Assurance department and external sources such as contract manufacturers (includes other quality related documents such as manufacturing licences etc.).
• Order of Certificates of Pharmaceutical Products (CPP) from various health authorities (Swiss medic, EMA, BfArM, etc.) and maintenance of order documentation.
• Order of postillations and legalizations of all types of documents in close co-operation with internal sources (e.g. Quality Assurance), affiliates and executing service providers.
• Organization of sample orders from initial order to dispatch (finished product, API, reagents, recipients) in close co-operation with ordering affiliates and internal departments, such as Supply Chain, Quality Assurance and Export
• General administrative support of off-site outsourcing partners (processing of incoming paper post, scanning, collection of signatures, courier dispatches, stamps, filing).
• Processing of subject related SAP tasks (invoice settlement, creation and maintenance of PO numbers).

Minimum Requirements

• 1-3 years experience in the field of Regulatory Affairs / pharmaceutical industry
• Good communication and negotiation skills
• Good command of German and English – both written and spoken
• Good user abilities in the computer environment: Microsoft Office, databases, SAP knowledge is an asset

Additional Skills

• Basic knowledge of international regulatory submission processes
• Basic knowledge of paralegal processes
• Familiarity with other regulatory functions such as regulatory operations & publishing, labelling, international submission support

• • Regulatory Affairs
  • SAP Products
  • Microsoft Office
  • English
  • German