Senior Regulatory Submissions Analyst (publishing)

Buckinghamshire (GB) and Home working
Competitive salary and benefits
08 Jan 2021
07 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)


  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Remote working initially with some office travel to Buckinghamshire
  • Competitive package available
  • Global pharma company



  • Publishes submissions within the European Region in line with current national and regional requirements for eCTD applications.
  • Works with regional archivists to ensure that published submissions are archived in accordance with local and global SOPs.
  • Provides guidance (and where necessary training) to European Region Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
  • Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities.
  • Works collaboratively with colleagues within the International Regulatory Submissions Team across the AMEA, Europe and LACAN regions.
  • Provides support and mentorship to junior colleagues within the team

Full job description available on application



  • Good knowledge of European pharmaceutical regulations and guidelines.
  • Experience in publishing CP, MRP and DCP submissions, including eCTD
  • Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
  • Knowledge/experience in publishing submissions for emerging markets (Middle East, Non-EU Europe etc) would be ideal.
  • Experience in eCTDs an NeeS essential
  • Ideally experience using Liquent
  • Only candidates with existing right to work in the UK/EU will be considered


Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email

To view our other vacancies, please visit our website on

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

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