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Job Details

Regulatory Affairs Associate - home based Italy. Permanent

Company: Novella Clinical Resourcing
Location: Home based Italy
Reference: NC-1721651RegsAssoc
Closing Date: 26 Nov 17
Type: Permanent
Salary (£): On Application
Benefits: Bench marked benefits

Job Summary:

Regulatory Affairs Associate required in Italy by Novella Clinical. Permanent, full time, home based role.

Requirements:

Novella Clinical, a Quintiles company, has a vacancy for a Regulatory Affairs Associate in Italy.

This is a permanent, full time role for an Italian speaker resident in Italy.

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 organizations.
  • 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. 
  • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
  • Serve as Novella liaison with central IRBs.
  • Perform other related duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Working knowledge of and aptitude for activities related to regulatory affairs  both domestic and international.
  • Familiarity with  regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with  principles of Good Clinical Practice
  • Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
  • Familiarity with or ability to assist  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.

MINIMUM RECRUITMENT STANDARDS:

  • Requires Bachelor's degree with at least 2 year of related work experience, science degree preferred or equivalent level of education and work experience.
  • At least one year of work experience in regulatory affairs
  • Excellent analytical and communication skills, particularly writing skills, are essential.
  • Fluency in Italian and English, both written and spoken.
  • Demonstrated computer literacy is required. 
  • Ability to travel a minimum of 20% both domestically and internationally is required.

To apply please submit your CV in Word format.

 

Key words: Regulatory Affairs Associate, Reg Affairs, Regulatory Affairs, Italy, clinical trial applications, CTAs, MAAs

 

 

 

 

Apply for this job: Regulatory Affairs Associate - home based Italy. Permanent

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
SG1 2ST
England
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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