Senior Associate Regulatory Affairs

7 days left

Location
England, Uxbridge, London
Salary
Negotiable
Posted
11 Jan 2021
Closes
25 Jan 2021
Ref
REGSNRASSO
Contact
Guy Shipman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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