Regulatory Dossier Consultant

Job Ref: J26371
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 23 April 2018
  • Buckinghamshire, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

The General Scope of Work will include planning and publishing regulatory submissions in eCTD, NeeS and Paper formats and submitting them according to EMEA-EM requirements to the respective health authorities and/or to the Local Operating Companies.

Responsibilities:

  • Establish dossier plans for the assigned submission types / projects in the EMEA-EM region considering inputs from functional area representatives and key stakeholders.
  • Ensure relevant submission processes are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
  • Interface with stakeholders and cross-functional representatives as appropriate to manage the dossier preparation process and ensure all aspects of the plan are coordinated and executed efficiently and with quality against KPIs.
  • Planning and tracking of submission events/activities in appropriate systems/tools.

  • Perform submission publishing activities in eCTD and non-eCTD format across all countries within the EMEA-Emerging Markets region according to applicable Health Authority (HA) and dossier formats.
  • Utilize current electronic document management and publishing tools to assemble, publish, validate and dispatch dossiers via electronic HA gateways or portals, or according to the EMEA-EM regional regulatory requirements for paper and electronic formats.

  • Perform QC of electronic and paper submissions to ensure compliance with HA and internal Janssen requirements, guidelines, and processes.

  • Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable.
  • Maintain openly, timely and effective communications with all dossier contributors and responsible RA professionals to ensure timely delivery of dossier components and/or complete dossier for submission.

Education:

  • University/Bachelor's degree or equivalent experience required and 2-4 years of experience required in the pharmaceutical industry or related experience.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
23/05/2018 14:53:15
GBP .