Regulatory Affairs Officer
Chiltern International - Wilmington, NC

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A Regulatory Affairs Officer required to act as a key member of the regulatory team.

Requirements:
Job summary

The Regulatory Affairs Officer will act as a key member of the regulatory team required to ensure the successful and timely submission of worldwide regulatory submissions.

The Regulatory Affairs Officer will provide support and advice to Regulatory Associates, and also provide regulatory intelligence to other team members, where required.

The Regulatory Affairs Officer may be called upon to interact independently with Sponsors not directly involved in their projects, and to assist in wider Departmental tasks.

Job Background:
An excellent opportunity has arisen to work in one of the fastest growing global Contract Research Organisations.

Chiltern is Europe’s largest privately owned full service (Phase I-IV) CRO, with over 1400 employees and 23 offices throughout Europe (both Eastern and Western), North and South America and Asia.

Job Primary Functions:
  • Provide regulatory support for assigned global clinical research projects interacting with the project team, the sponsor and the regulatory authorities on regulatory and technical matters in order to obtain clinical trial approvals from regulatory authorities.
  • Conduct critical reviews of key technical documents (e.g. clinical trial protocols and reports, existing regulatory dossiers and other related technical documentation).
  • Submission all documentation destined for concerned authorities to another senior member of the Chiltern Regulatory team for internal Quality Control check.
  • Design and complete regulatory deliverables (e.g. clinical trial applications, investigational new drug applications, etc.) for assigned projects; interface with clients as appropriate.
  • Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
  • Keep up to date with current, worldwide regulatory knowledge, trends and developments.
  • Provide support to both existing and emerging global markets
  • Liaise with regulatory authorities in order to respond to regulatory comments.
  • Perform IP release.
Job Qualifications:
  • Life Sciences degree.
  • Postgraduate Qualification preferred.
  • A proven experience in the preparation of regulatory submissions including IND, NDA, MAA, CTD and clinical trial applications.
  • Good understanding of the principles of ICH GCP and worldwide regulatory legislation, guidelines and customer practice.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Excellent communicator, with highly proficient communication skills in English when dealing with both internal and external clients, and strategic and tactical issues. A persuasive speaker and good listener.
  • Customer focus.
  • Well developed organisational skills
  • Ability to work as part of a team under time and resource pressures.
MORE INFORMATION AVAILABLE ON REQUEST

For a confidential discussion about this opportunity, please phone Martin Painter on +44 (0) 1245 465341. To apply, please send your CV to martin.painter@chiltern.com

For more information about Chiltern, please visit our web site at www.chiltern.com

Key words : Regulatory Affairs

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