Regulatory Affairs Project Manager

Job Type:
Contract
Job Sector:
Scientific
Region:
South East
Location:
Berkshire
Salary:
£450 to £550 per day
Salary Description:
£450 - £550 per day
Posted:
04/03/2020
Recruiter:
Hyper Recruitment Solutions
Job Ref:
J5633068

We are currently looking for a Regulatory Affairs Project Manager to join a leading Pharmaceutical company based in the Berkshire area for an initial three months. As the Regulatory Affairs Project Manager you will be responsible for compiling and submitting Marketing Authorisation Applications (MAA) in line with EU and global submission requirements.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Project Manager will be varied however the key duties and responsibilities are as follows:

1. Work with SME's to submit CMC (Module 3) and labelling variations in line with DCP / MRP Centralised procedure

2. Compile and submit labelling variations (DCP/MRP) in line with variation, SOPs and Authority requirements

3. The Regulatory Affairs Project Manager will select and manage appropriate CMO's / vendors for product labelling and artwork purposes and liaise with the artwork coordinator

4. Ensure submissions are made to EU and Global markets within agreed timeframes

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Affairs Project Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific discipline

2. Proven industry experience in compiling Marketing Authorisation Applications (Including CMC and labelling variations (DCP/MRP) for products in EU and Global Markets

3. A working knowledge and practical experience with writing and reviewing CMC Regulatory documents for submission to relevant authorities

Key Words: Regulatory Affairs / RA / Module 3 / CMC / Pharmaceutical / Contract / Pharmaceutical / Science / Project Manager / API / Documentation / Berkshire / MRP / DCP / Contract

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.

Contact Details:
Hyper Recruitment Solutions
Tel: 0203 910 2980
Contact: Fabio Roque
Email:

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