Principal Regulatory/Medical Writer (Vaughan)

About the Role

Apsida Life Science is partnering with a long‑standing regulatory writing consultancy that has been supporting global pharmaceutical organizations for over 20 years. This role will support the company’s growth in North America by working as a Principal Regulatory Writer based in Canada or the US, with a 0.8 FTE working model.

Renowned for their scientific excellence, team‑oriented culture, and strategic expertise, the organization offers the opportunity to work across a diverse portfolio of projects spanning a wide range of therapeutic areas.

Responsibilities

• Be the point of contact for specific project deliverables, managing the technical and scientific aspects of leadership 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 the delivery of clear, accurate, well‑written documents.
• Support the Project Management team with development or review of budgets against project specifications, if required.

Qualifications

• Degree in Life Science or a related area.
• Minimum of 5+ years of experience in Regulatory Writing.
• Experience authoring/leading CTD Module 2 submissions – 2.7.3 and 2.7.4.
• Proven experience as a Senior/Principal Regulatory Writer.