Job Opportunity

Reference: QS01061
Title: Pharmaceuticals Regulatory Affairs Specialist
Location: Homebased
Job Type: 10 months contract
Salary: PAYE rate is £46.86 per hour
Contact Person: Miss Rashida Khan apply@qualitystart.co.uk

Opportunity: This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for drug products.

Do you have experience in product labelling activities and regulatory drug submissions in preparation for the Windsor Framework for the UK market? Have you compiled regulatory documents for submissions within the UK and European Union countries? Looking for a contract role with an exciting global pharmaceutical company? If yes then this is the role for you.

Your role as a Pharmaceuticals Regulatory Affairs Specialist based working from home or in the office will involve coordinating, preparing and submitting medicinal product labelling activities and associated regulatory submissions in preparation for the Windsor Framework.

Duties and responsibilities include:

• Compiling regulatory documents for submissions for the UK and EU countries.
• Editing and proofreading regulatory documentation for submissions.
• Supporting regulatory project plan execution.
• Maintaining awareness of regulatory requirements relating to Windsor Framework.
• Fostering and maintaining internal relationships with Labelling Operations.

This is a 10 months contract role which will be reviewed for a possible extension or go permanent but this is all dependent on the individual and business performance.   This is a role based working from home and to attend the office as and when required which is located in Newbury, Berkshire.  There is also the option to be on site every day.

The PAYE rate is £46.86.  

Skills: To apply for role of Pharmaceuticals Regulatory Affairs Specialist you will have the following:

• Bachelor’s degree or equivalent in a relevant scientific discipline with experience of UK drugs regulatory labelling requirements, Regulatory Authority submissions and Regulatory Authority communication/negotiation.
• Excellent project management skills.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Proofreading and editing skills.
• Good project management experience.

How to Apply: In order to apply for this vacancy please ensure you have read and agree to the privacy policy found here and then email your CV to apply@qualitystart.co.uk quoting the reference number and the job title.