Regulatory Consultant - CMC and Labelling

Location
Reading
Salary
£50 to £70 per hour
Posted
07 Jun 2019
Closes
05 Jul 2019
Ref
J5631634
Contact
Gary Eldridge
Contract Type
Contract
Hours
Full Time
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:

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

Key Words: CMC / Regulatory Affairs / Labelling / SmPC / PILs / Labels / CMC / DCP / MRP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.

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