Regulatory Affairs Consultant

Pharma Design Limited; Dortmund; Remote; EUR 80.000 - 100.000; Teilzeit

Zusammenfassung

A consulting firm is seeking a part-time, fully remote Regulatory Consultant with expertise in EU food-contact legislation. The role involves providing advice and preparing documentation for the regulatory filing of a smoking cessation device. Ideal candidates should have a strong understanding of relevant EU regulations. Previous consultancy experience is essential.

Qualifikationen

• Proven experience with EU food-contact legislation including 1935/2004, No 10/2011, and related regulations.
• Experience preparing documentation for regulatory filings.
• Familiarity with smoking cessation device guidelines.

Aufgaben

• Provide regulatory advice to ensure compliance with EU food contacts.
• Prepare documentation for EU and UK filings.
• Perform hands-on work related to food-contact legislation.

Kenntnisse

Experience with EU food-contact legislation

Knowledge of plastic materials

Understanding of inhaler guidance

Jobbeschreibung

Role Description

This is a part-time, fully remote, contract role for a Regulatory Consultant with experience in EU food contact legislation at Pharma Design Limited for a freelancer. Please don't apply if you are not an independent consultant or do not have your own consultancy business.

The consultant will need to provide advice and perform hands-on work on preparing all relevant documents pertaining to the EU and UK filing of a smoking cessation device where food-contact legislation, plastic materials, container closure system and inhaler guidance will be key.

Qualifications & Experience

• Experience with EU food-contact legislation including 1935/2004 (Framework)
• EU No 10/2011 (Plastic Material)
• EU 2018/213
• 93/11/EEC
• EC 1895/2005
• EC No 2023/2006