EU Regulatory Affairs Consultant (Oncology)

High Wycombe  ‐ Onsite
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Keywords

Description

The successful candidate will;
  • Participate in global regulatory team meetings as appropriate
    Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
  • Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
  • Assist in development of processes related to regulatory submissions
  • Draft and review some document content
  • Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
  • Track dates of submissions and Regulatory Agency responses
    Review protocols and ensure alignment with regulatory requirements
  • Advise team on required documents and submission strategies in preparation of Clinical Trial Applications (CTAs)
  • Ensure Clinical Trial Application (CTA) submission packages are complete and available according to agreed timelines
  • Review and approve clinical trial supply plans
  • Provide regulatory support throughout registration process
  • Provide regulatory support throughout life-cycle management
  • Advise team on required documents and submission strategies in preparation of Marketing Authorization Applications (MAAs) as assigned (in collaboration with LOCs as appropriate)
  • Assist with timely Marketing Authorization Application (MAA) availability, ensure that all document components are in place on time, identify and track critical path activities
  • Assist with submission and acceptance of Marketing Authorization Application (MAA)


Experience:
  • Relevant life science degree
  • Hands on experience in Regulatory Affairs
  • Experience with EU markets essential
  • Experience in Oncology therapeutics highly desirable
  • Strong verbal and written communication skills
  • Demonstrated ability to work effectively to project deadlines
Start date
04/2014
Duration
6 Months
From
Real Staffing
Published at
19.03.2014
Project ID:
681321
Contract type
Freelance
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