Regulatory Affairs Project Manager (Consultant)

Location
Berkshire
Salary
£300 to £700 per day
Posted
06 Apr 2017
Closes
04 May 2017
Ref
J3786
Contact
Gary Eldridge
Contract Type
Contract
Hours
Full Time
Hyper Recruitment Solutions are currently recruiting for a Regulatory Affairs Project Manager Consultant to join a leading pharmaceutical company on a contract basis, based in the Berkshire area. As the Regulatory Affairs Project Manager you will be responsible for maintaining marketing authorisations for a portfolio, liaising with Marketing, Medical, Supply Chain, QA/QP, Pharmacovigilance and STADA teams. You will also communicate key regulatory issues that may affect product developments or product launches.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will prepare, submit and coordinate national Marketing Authorisation Applications in accordance with local, EU, and global submission requirements.

2. As the Regulatory Affairs Project Manager 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.

4. As the Regulatory Affairs Project Manager you will provide QPs with current licence information to ensure product is released to respective markets in compliance with their registered technical details in that market (MA licence).

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 experience of handling complex licences in terms of full submissions and maintenance.

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

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.