Principal Regulatory Writer

Position: Principal Regulatory Writer Apsida Life Science
Elevate your career with Apsida Life Science as a Principal Regulatory Writer in Canada or the US. This role involves leading high-complexity programs and ensuring accurate regulatory submissions.

Apsida Life Science collaborates with a reputable regulatory writing consultancy, serving global pharmaceutical clients for over twenty years. As a Principal Regulatory Writer, you will guide strategic projects, focusing on CTD Module 2 submissions. Your expertise will ensure clear and well-crafted documents while supporting project management in budget development and reviews.

Key Responsibilities:

• Oversee technical and scientific aspects of client accounts

• Lead complex CTD Module 2 submissions (2.7.3, 2.7.4)

• Ensure accuracy and transparency in regulatory documents

• Collaborate with Project Management on budget specifications

Requirements:

• Degree in Life Science or related area

• 5+ years of experience in Regulatory Writing

• Proven success in leading CTD Module 2 submissions

• Background as a Senior or Principal Regulatory Writer

Drive impactful submissions and document excellence at Apsida Life Science.
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