Principal Regulatory​/medical Writer

Apsida Life Science is partnering with a long-standing regulatory writing consultancy that has supported global pharmaceutical organisations for over two decades.
The consultancy offers a diverse portfolio of projects across a range of therapeutic areas and seeks a Principal Regulatory Writer based in Canada or the US to expand their North American presence.

This role offers a 0.8 FTE working model.
Responsibilities   Act as point of contact for specific project deliverables, overseeing the technical and scientific aspects of designated client accounts.
Lead strategic and high‑complexity programs, including CTD Module 2 submissions (2.7.3, 2.7.4).
Provide technical and scientific expertise to ensure the delivery of transparent, accurate, well‑written documents.
Support the Project Management team with development or review of budgets against project specifications, when required.
Requirements   Degree in Life Science or a related area.
Minimum of 5+ years’ experience in Regulatory Writing.
Experience authoring or leading CTD Module 2 submissions (2.7.3 and 2.7.4).
Proven experience as a Senior/Principal Regulatory Writer.
Contact  If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science.

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