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Job Details

Regulatory Affairs Manager

Company: CROMSOURCE
Location: Europe
Reference: HQ00001461
Closing Date: 18 Jan 19
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

: Regulatory Affairs Manager : Europe - Netherlands OR United Kingdom Schedule: Full time, permanent, Home based     CROMSOURCE, an international, full service CRO, is looking for an experienced Regulatory Affairs Manager to join our team in Europe, to support the Regulatory Affairs Unit in the regulatory and logistics management of clinical and medical device studies   Main Job Tasks and Responsibilities Collects study-related and country-related regulatory...

Requirements:

Job Title: Regulatory Affairs Manager

Location: Europe - Netherlands OR United Kingdom

Schedule: Full time, permanent, Home based

CROMSOURCE, an international, full service CRO, is looking for an experienced Regulatory Affairs Manager to join our team in Europe, to support the Regulatory Affairs Unit in the regulatory and logistics management of clinical and medical device studies

Main Job Tasks and Responsibilities

  • Collects study-related and country-related regulatory information for submission in order to ensure compliant performance, according to defined regional responsibility
  • Updates and maintains country-specific regulatory information to ensure regulatory knowledge is up to high standards
  • If delegated, supports and performs the quality check of the Competent Authorities submission packages within timeframes required by CAs and by the Project Leaders or delegates guaranteeing their completeness and compliance with legal regulations for studies with medicinal products and medical devices
  • Participates in external training, reads professional publications, maintains personal networks to keep knowledge concerning regulatory affairs up-to-date
  • Develops regulatory related training materials providing operational support
  • Performs Regulatory Affairs training
  • Leads, performs or supports regulatory consulting services under the supervision of the Head of RA Unit (e.g. prepare, compile and submit regulatory applications related to market authorization and any clinical trial/investigation application to FDA and associated regulatory authority in US (excludes are IRBs and bioethics committee submissions)
  • Prepares clinical literature or evaluation reports for MD, writes clinical study reports, performs GAP analysis of Technical Files/Design Dossier)
  • Develops procedures and templates required for the provision of regulatory consulting services

Education and Experience

  • You have a University Degree in scientific medical or paramedical disciplines
  • Knowledge of ISO 9001, ICH-GCP, MDD, AIMDD, ISO EN 14155, relevant MEDDEVs and EUCTD, relevant European and National regulations
  • Previous experience in a similar role
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook

If you would like to be considered for this exciting opportunity pleased send your CV directly to vicki.wilson@cromsource.com

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

Regulatory Affairs Manager, Regulatory Manager, Regulatory Submissions, Regulatory Affairs Project Manager

Regulatory Affairs Manager

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Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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