Principal Regulatory Writer in North America

Location: New Westminster

Apsida Life Science is seeking a Principal Regulatory Writer in Canada or the US to enhance support for global pharmaceutical clients. This pivotal role focuses on high-complexity submissions and technical expertise.

As a Principal Regulatory Writer, you will manage key project deliverables and oversee strategic client interactions. With over five years of regulatory writing experience, you’ll take the lead on CTD Module 2 submissions while ensuring precision in all documentation. This role provides a potential 0.8

FTE working arrangement.

Key Responsibilities:

• Manage designated client accounts and deliverables

• Lead strategic CTD Module 2 submissions

• Provide technical expertise for document accuracy

• Collaborate with Project Management on budgets

Requirements:

• Degree in Life Science or related field

• Minimum of 5 years’ regulatory writing experience

• Expertise in CTD Module 2 submissions

• Proven background as a Senior or Principal Writer

Leverage your regulatory writing skills and join Apsida Life Science to shape the future of pharmaceutical documentation.
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