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Vacancy details
Vacancy description:
Job Code:
327533
Job Title:
Regulatory Affairs Specialist, PERM
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Clinical Project Manager, Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire
Min experience:
4 years
Annual salary:
Negotiable (Up to 50000 £)
Apply by:
30 May 2008
Accountabilities/Responsibilities:
Producing global clinical trial applications, clinical study reports, publications and
summary documents.
Producing expert reports, investigator brochures, and supporting regulatory
documentation.
Acting as the RAPM for designated complex projects and manages the regulatory affairs
aspects of the project.
Participating in Global project Teams where necessary
Ability to provide strategic regulatory advice to clients on their proposed clinical
development plan
Ability to become ”expert” in new therapeutic areas
Able to assess CMC, preclinical and clinical data for NCEs, biotechnology and other
therapies
Assisting in the management of projects in line with budgets and agreed timelines to
achieve client satisfaction.
Sourcing appropriate data, information and documentation from clients and/or their
nominees to fulfil regulatory requirements.
Supporting regulatory affairs management in ensuring departmental awareness and
compliance of current local, national, regional and harmonised guidance and
requirements for the format, content and control of all types of regulatory procedures
and submissions.
Education
Graduate, postgraduate, 4-year college degree, or equivalent, ideally in a scientific or
healthcare discipline.
Experience
5 years or more experience of regulatory affairs in either a CRO or pharmaceutical
industry with some experience of strategic development experience (minimum 2years).
Extensive experience of global clinical trials.
Ability to interpret CMC, preclinical and clinical data
Previous experience of writing key regulatory documents e.g. IMPD
Previous participation in EU regulatory submission process
Skills
Demonstrates an excellent knowledge of ICH-GCP, global regulatory guidance and
relevant SOPs.
Demonstrates ability to develop and maintain a regulatory affairs contact network.
Demonstrates a good knowledge of clinical trials methodology.
Demonstrates a working knowledge of protocols and indications being studied.
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