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Job Details

Regulatory Affairs Specialist - Home based - Permanent

Company: Novella Clinical Resourcing
Location: UK
Reference: NC - 1023815
Closing Date: 28 Jul 18
Type: Permanent
Salary (£): Competitive

Job Summary:

We have current requirements for an experienced Regulatory Affairs Specialist to join the Novella team.


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.


·        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. 


·        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.

·        Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice, ISO standards.

·        Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.

·        Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.

·        Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public. 

·        Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.

·        Ability to read and synthesize technical material and to prepare clear and concise written documents.

·        Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.


·        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. 

·        Excellent analytical and communication skills, particularly writing skills, are essential. 

·        Demonstrated computer literacy is required. 

·        Ability to travel a minimum of 20% both domestically and internationally is required.

Apply for this job: Regulatory Affairs Specialist - Home based - Permanent

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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