Scientific
Scientific

Senior Regulatory Submissions Analyst

Buckinghamshire

Scope

This is a fantastic opportunity for a regulatory affairs professional with experience in regulatory publishing looking to develop their experience with an established global pharmaceutical company.

Responsibilities

  • Publishes regulatory 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.

About You

  • 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.
  • Excellent knowledge of submission guidance documents and regulations. Ability to independently review and adopt new/changing regulatory guidance into existing processes.
  • Ability to multi-task, prioritize, and manage multiple projects and deadlines
  • Sense of personal responsibility and accountability
  • Due to the Senior position, the ability to mentor and support junior team members.
If you are interested in the above role then please apply or get in touch to discuss further.
Ed Curl Managed by Ed Curl
highlights
South East
Contract
Technical
apply Posted - 14.01.2021

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Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.