Principal Regulatory Writer North America

Elevate your career as a Principal Regulatory Writer with Apsida Life Science, supporting clients across North America. This role emphasizes strategic projects and complex CTD Module 2 submissions.

Apsida Life Science is seeking an experienced Principal Regulatory Writer based in Canada or the US. You will lead high-complexity submissions and manage deliverables for designated client accounts. This position offers the flexibility of a 0.8 FTE working model while contributing to diverse therapeutic projects for global pharmaceutical organizations.

Key Responsibilities:

• Manage specific project deliverables for clients

• Lead submissions, particularly CTD Module 2 tasks

• Ensure the delivery of accurate, clear documents

• Provide technical expertise throughout the project

• Support project budgeting alongside management team

Requirements:

• Degree in Life Science or related area

• Minimum 5+ years in Regulatory Writing

• Experience authoring CTD Module 2 submissions

• Proven track record as a Senior/Principal Writer

Leverage your regulatory writing expertise and strategic skills to enhance Apsida Life Science's project portfolio.
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