Company: Novella Clinical Resourcing
Reference: NC - 1625940
Closing Date: 05 Feb 17
Salary (£): Competitive
We have current requirements for an experienced Regulatory Affairs Specialist/Associate to join the UK team on a contract and permanent basis.
You will provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organisations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies).
· Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organisations.
· Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
· Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
KNOWLEDGE, SKILLS AND ABILITIES:
· Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
· Familiarity with or ability to become familiar with regulatory documents, general contents, organisation and the methods of filing and tracking.
MINIMUM RECRUITMENT STANDARDS:
· Requires Bachelor's degree with at least 3 years of related work experience, science degree preferred or equivalent level of education and work experience.
· Two or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
For more information and to apply for this role please forward an updated CV to Jemma Smith - firstname.lastname@example.org
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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