Regulatory Publishing Senior Associate

Highly Competitive
  1. Permanent
  2. Publishing & Submissions
  3. United Kingdom
London, England
Posting date: 27 Sep 2019
RA.RE.25552_1569604136

An international research organisation is seeking to recruit a Regulatory Publishing Senior Associate to their office in London. This Contract Research Organization (CRO) provides a broad range of product development and data solution services to pharmaceutical and biotechnology companies around the world. This position is an exciting opportunity to work with an award-winning and globally renowned CRO.

Job Responsibilities:

  • Acting as the primary publisher for various regulatory submissions (including NeES, eCTD, and paper formats), setting the strategy for the submission.
  • Planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submissions forecast and managing timelines and quality.
  • Liaising with other stakeholders, including Regulatory Affairs, Submission Managers etc to ensure submission requirements and timelines are agreed upon.
  • Analyse regulatory guidelines and regulatory documentation practices to ensure compliance.
  • May also serve as Subject Matter Expert for various publishing tools or dossier types.
  • Focus on the lifecycle submissions portfolio, you may also work on departmental initiatives, process improvement, validation testing, or highly complex submissions.

Skills and Requirements:

  • Bachelor's degree in a relevant field of study.
  • Experience with eCTDXpress and/or Liquent IP preferred but not essential.
  • A strong understanding of regulatory requirements and submission processes.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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