Regulatory Affairs Submissions Consultant

Location
Berkshire
Salary
£60 to £75 per hour
Posted
25 May 2017
Closes
22 Jun 2017
Ref
J3786
Contact
Gary Eldridge
Contract Type
Contract
Hours
Full Time
Hyper Recruitment Solutions are currently recruiting for a Regulatory Affairs Submissions Consultant to join a leading pharmaceutical company on a contract basis, based in the Berkshire area. As the Regulatory Affairs Submissions Consultant you will be responsible for project managing a submission for new products and product changes.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Project Manage an EU submission for new product and product changes

2. As the Regulatory Affairs Submissions Consultant you will finalise the national phase of Marketing Authorisation Applications submitted via the EU Mutual Recognition/Decentralised Procedures (generation of Patient Information Leaflet, product labelling and artwork, etc).

3. You will compile and submit CMC variations (CP/DCP/MRP/National) in line with the variation regulation, SOPs (where relevant) and national Competent Authority requirements.

ROLE REQUIREMENTS:

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

1. Relevant degree in Life Sciences.

2. Significant Regulatory Affairs submissions experience

3. A working knowledge and practical experience dealing with the Health authorities.

Key Words: Global marketing authorisations, decentralised procedures, artwork, life cycle management, submissions, variations, pharmaceutical, regulatory affairs, CMC, TOPRA, submissions

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.