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Principal Regulatory/Medical Writer
Job Description & How to Apply Below
Apsida Life Science is partnering with a leading regulatory writing consultancy and is seeking a Principal Regulatory Writer based in Canada or the US. The role supports the company's North American expansion and offers a 0.8 FTE working model.
Responsibilities Act as point of contact for specific project deliverables and manage technical and scientific aspects of designated client accounts.
Lead strategic and high‑complexity programs such as submissions, including CTD Module 2 (2.7.3, 2.7.4).
Provide technical and scientific expertise, ensuring delivery of clear, accurate, well‑written documents.
Support the Project Management team in developing or reviewing budgets against project specifications, if 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 or Principal Regulatory Writer.
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