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Regulatory Consultant - CMC and Labelling

BerkshireTemporary
£50 - £70 per hour
Job Reference: J5631634
Updated On: 07/06/2019
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical

Skills: Regulatory Affairs - Contract, Regulatory Affairs - EU, Regulatory Affairs - CMC

Job Information

Role Overview

We are currently looking for a Regulatory Affairs Consultant to join a leading pharmaceutical company based in the Berkshire area. As the Regulatory Consultant you will be responsible for CMC Gap analysis and authoring of module 3, and evaluating manufacturing and labelling changes.

Key Duties and Responsibilities

Your duties as the Regulatory Consultant will be varied however the key duties and responsibilities are as follows:

1. Evaluating manufacturing and labelling changes, liaising with and advising other internal departments of implementation timelines and data requirements.

2. Managing routine Marketing Authorisation maintenance activities DCP/MRP/National including compilation and submission of variations. Ensures Marketing Authorisation compliance, timely submission of variations.

3. Ensuring new product artwork is generated in line with regulatory requirements and to agreed timescales. Managing the process for MA post-approval artwork amendments.

Role Requirements

We are currently looking for a Regulatory Affairs Consultant to join a leading pharmaceutical company based in the Berkshire area. As the Regulatory Consultant you will be responsible for CMC Gap analysis and authoring of module 3, and evaluating manufacturing and labelling changes.

KEY DUTIES AND RESPONSIBILITIES:
To be successful in your application to this exciting opportunity as the Regulatory Consultant we are looking to identify the following on your profile and past history:

1. Previous experience providing updates to SmPC, PILs and labels

2. Proven industry experience in managing the submission and approval of Article 61(3), Type I and II variations within the EU under DCP/MRP in human medicines

3. A working knowledge and practical experience with manufacturing site transfers and CMC gap analysis
Gary Eldridge
Your Recruitment ConsultantGary Eldridgegary.eldridge@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.