Regulatory Submission Specialist

Job Ref: J33737
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Contract
Date Added: 09 October 2019
  • Berkshire, England, UK Berkshire Berkshire UK SL6 4UB
  • Competitive
    HOUR
  • Natasha Rollason
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SRG are currently looking for Regulatory Submissions Specialist for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Berkshire.

The Role:

You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team.

Key Responsibilities:

  • Creation, formatting and filing of documents for electronic submissions to ensure that they are "submission ready", working with Area and Affiliate regulatory personnel.
  • Perform pre-publishing tasks to ensure timely set up and maintenance supporting the publishing of regulatory submissions including Registration Management tasks, where applicable.
  • Expedite and coordinate a multitude of interrelated activities for a submission team, including Module 1 planners, in the development of published submissions within the required timelines.
  • Assist with co-ordination of publishing carried out by offsite contractors, including support for work allocation, resolution of queries and team review.
  • Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely despatch and archival of regulatory submissions, and effective maintenance of supporting documentation.
  • Liaise and attend meetings with other company functions to meet submission timelines and plans.

Skills/Experience Required:

Education

Life Sciences Degree qualified.

Knowledge

  • Experience of working in a regulatory submissions or registration management environment preferred
  • Documentum / XML, eCTD & NeeS experience preferred
  • Essential to work accurately and pay close attention to detail
  • Quick to learn new IT systems and processes and the ability to thrive in a changing environment and to re-prioritise workload to meet business needs

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

SRG
08/11/2019 15:55:17
GBP