Senior Regulatory Affairs Associate

Job Type:
Job Sector:
South East
United Kingdom
£25 to £30 per day
Salary Description:
£25 - £30 per day
Quanta Consultancy Services Ltd
Job Ref:

The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects. 

Key responsibilities include: 
• Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission) 
• Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead 
• Coordinate collection of functional documents in support of regulatory applications 
• Prepare regulatory packages and cross-reference letters to support investigator sponsored studies 
• Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies 
• Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications 
• As appropriate may participate in GRT to support execution of regulatory strategy 
• Respond to specific requests from and communicate relevant issues to GRT 
• Support the development and execution of GRT goals 
• Review regional component of the Global Regulatory Plan and provide input to operational deliverables 
• May support RRL in review of promotional materials for commercial activities 
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams 
• Support process improvement initiatives, standards development, and metrics 

Key Skills include: 
• Strong communication skills - oral and written 
• Organizational skills 
• Understanding of drug development process



To view Quanta's privacy policy, please visit our website

Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 860 542
Contact: Kathryn Taylor

You may return to your current search results by clicking here.


This website uses cookies. Read our cookie policy for more information. By continuing to browse this site you are agreeing to our use of cookies.

Latest Job Listings