Senior Associate Regulatory Affairs

7 days left

England, Uxbridge, London
11 Jan 2021
25 Jan 2021
Guy Shipman
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Senior Associate Regulatory Affairs

12 month contract

£31.01 per hour maximum pay

Working with Oncology Team
Candidate can work at either site Uxbridge or Cambridge

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

Candidate requirements:

- Degree qualified
- Similar prior experience at an innovative pharmaceutical company, ideally with oncology experience

Key Skills include:

  • Strong communication skills - oral and written
    * Organizational skills
    * Understanding of drug development process

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