Regulatory

Job Ref: J22947
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 25 July 2017
  • Berkshire, England, UK
  • n/a
  • Natasha Rollason

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The Role:

To 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 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: 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.