Principal Regulatory/Medical Writer (Terrebonne)

Apsida Life Science is partnering with a long-standing client, a well-established regulatory writing consultancy that has been delivering strategic support to global pharmaceutical organisations for over 20 years.

Comprised of experienced scientific and regulatory specialists, the team helps clients navigate complex regulatory challenges and critical decision-making throughout the product lifecycle.

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

As part of their continued growth, they are now seeking a Principal Regulatory Writer based in Canada or the US to play a key role in expanding their presence and supporting clients across the North American market.

Please note: this role offers the possibility of a 0.8 FTE working model.

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, and ensuring the delivery of explicit, accurate, well-written documents.
• Support the Project Management team with development or review of budgets against project specifications, if required.

Requirements

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

If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:

US Direct:

UK Direct: +44(0)

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.