Principal Regulatory Writer

Position: Principal Regulatory Writer Apsida Life Science
Join Apsida Life Science as a Principal Regulatory Writer, contributing to strategic support in the regulatory writing consultancy.

This role offers the chance to enhance your leadership in pharmaceutical regulatory communications across North America.

Apsida Life Science is seeking a Principal Regulatory Writer to bolster its consultancy services in Canada or the US. Leverage your expertise, particularly in CTD Module 2 submissions, to guide clients through complex regulatory landscapes. This position involves managing client accounts and providing high-quality document deliverables while being involved in a flexible 0.8 FTE working model.

Key Responsibilities:

• Manage specific project deliverables for client accounts

• Lead high-complexity regulatory programs and submissions

• Ensure the accuracy of well-crafted technical documents

• Support budget development and review with Project Management

Requirements:

• Degree in Life Science or related fields

• Over 5 years’ experience in Regulatory Writing

• Expertise in leading CTD Module 2 submissions

• Proven background as a Senior/Principal Regulatory Writer

Utilize your regulatory writing expertise to support Apsida Life Science's clients effectively.
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