Senior Regulatory Affairs Associate

Job Type:
Permanent
Job Sector:
Research
Region:
South East
Location:
United Kingdom
Salary:
£25 to £30 per day
Salary Description:
£25 - £30 per day
Posted:
21/01/2019
Recruiter:
Quanta Consultancy Services Ltd
Job Ref:
21999

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

 

 

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

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