Regulatory Affairs Expert for Clinical Deliverables

1 week ago


London, Greater London, United Kingdom Healthcare Businesswomen's Association Full time

We are seeking a skilled Regulatory Affairs Specialist to join our team at the Healthcare Businesswomen's Association in London, White City. This is an exciting opportunity to leverage your expertise in clinical document publishing and global regulatory submissions.

About Us

Our organization is guided by a purpose to reimagine medicine and improve people's lives. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

The Role

This is a hybrid role requiring 3 days per week in-person work at our office in White City, London, with ad-hoc working hours to overlap with the US as needed.

  • You will be accountable for preparing, publishing, quality reviewing, validating, dispatching, and archiving clinical deliverables and global regulatory submissions electronically.
  • Your primary responsibility will be to produce high-quality clinical deliverables and global submission outputs within agreed timelines and in compliance with worldwide health authority requirements, internal working practices, and guidelines.
  • You will support the implementation of new technology, tools, and processes, contribute to ongoing initiatives and training, and help identify continuous improvement opportunities.
Requirements

To be successful in this role, you must have:

  • A Bachelor's degree in life sciences or a relevant discipline.
  • Fluency in English.
  • Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
  • Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).
  • Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
  • Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, EMA).
  • Strong interpersonal and project management skills, and experience working in a complex, global cross-functional organization.
Benefits

As a member of our team, you can expect a competitive salary, approximately £60,000 - £80,000 per annum, depending on experience, plus benefits that include hybrid working arrangements, professional development opportunities, and a dynamic work environment.

How to Apply

If you are passionate about regulatory affairs and eager to take on a new challenge, please submit your application.



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