Principal Regulatory Writer in North America

Elevate your career with Apsida Life Science as a Principal Regulatory Writer, supporting North American clients in the pharmaceutical sector. This role involves strategic regulatory writing with a focus on CTD Module 2 submissions.

Apsida Life Science is looking for an experienced Principal Regulatory Writer to enhance their North American presence. This position requires a minimum of five years in regulatory writing, specifically with CTD Module 2 submissions. You'll provide scientific expertise, manage client accounts, and ensure the accuracy of critical documentation for diverse therapeutic projects.

Key Responsibilities:

• Manage technical aspects of designated client accounts

• Lead complex programs for submissions, focusing on CTD Module 2

• Deliver clear, accurate, and well-written regulatory documents

• Support budget development and reviews as necessary

Requirements:

• Degree in Life Science or related field

• 5+ years of experience in Regulatory Writing

• Expertise in leading CTD Module 2 submissions

• Proven background as a Senior or Principal Regulatory Writer

Utilize your regulatory writing expertise to drive success for clients across North America at Apsida Life Science.
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