Regulatory Affairs Consultant

Pharma Design Limited; Altrincham; Remote; GBP 100,000 - 125,000; Part time

Job summary

A consultancy service provider is seeking a part-time remote Regulatory Consultant to manage EU and UK filings for a smoking cessation device. The ideal candidate must have extensive experience with EU food-contact legislation and be capable of preparing necessary documents. This opportunity is exclusively for freelancers or those with their own consultancy business.

Qualifications

• Must have experience with EU food-contact legislation.
• Expertise in regulatory submissions and documentation.
• Ability to work independently as a consultant.

Responsibilities

• Provide advice on EU and UK filing of a smoking cessation device.
• Prepare all relevant documents pertaining to food-contact legislation.
• Ensure compliance with container closure system and inhaler guidance.

Skills

Experience with EU food-contact legislation

Understanding of 1935/2004 Framework

Knowledge of EU No 10/2011 Plastic Material

Familiarity with EU 2018/213

Expertise in 93/11/EEC

Knowledge of EC 1895/2005

Understanding of EC No 2023/2006

Job description

Company Description

Pharma Design Limited (PhD) is a London-based service provider specializing in helping pharmaceutical companies gain marketing authorizations in Europe.

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. Please do not apply if you are not a freelancer or 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 1895/2005
• EC No 2023/2006