Regulatory Dossier Manager

Job Ref: J31614
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 24 April 2019
  • Macclesfield, Cheshire, England, UK Macclesfield Cheshire UK SK10 2NA
  • Competitive
    HOUR
  • Natasha Rollason
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team. They are looking to recruit a Regulatory Dossier Manager on an initial 12 Month contract basis to their offices in the Macclesfield.

The Role:

As a dossier manager you will produce and support the production and regulatory submission of Chemistry, Manufacturing and Control documentation for commercial products at various stages of the product life-cycle, in the required format and to the agreed timetable. You will work in partnership with relevant product and project teams support regulatory submissions.

Key Responsible:

  • Coordinate the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes.
  • Support the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities
  • Review and approve regulatory CMC documents on behalf of Operations Regulatory
  • Support the progression and delivery of cross-functional documentation required by Global Regulatory Affairs for inclusion in worldwide regulatory submissions
  • Maintenance of electronic systems to ensure the current regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received

Education:

  • Graduate in a scientific discipline e.g. chemistry, pharmacy or biological science or experience in the Pharmaceutical industry preferably within a regulatory QA or QC environment.
  • Excellent IT skills
  • Delivery focus with ability to effectively manage workload
  • Basic knowledge of the drug development process
  • Experience of authoring technical documents
  • Understanding of current regulatory CMC requirements and the contents of Modules 1, 2 and 3 of the Common Technical Dossier

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
24/05/2019 08:35:57
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