Regulatory Affairs Associate - Submissions

Job Ref: J23735
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 27 September 2017
  • Berkshire, England, UK
  • Competitive
  • Natasha Rollason

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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 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.