Principal Regulatory Writer

Position: Principal Regulatory Writer Apsida Life Science
Elevate your career with Apsida Life Science as a Principal Regulatory Writer in North America. This role focuses on high-complexity submissions and regulatory writing expertise.

Joining a well-established regulatory writing consultancy, you will leverage over five years of experience to manage client accounts and lead submissions like CTD Module 2.

This role offers the chance to work in a collaborative environment across diverse therapeutic areas while supporting project management initiatives to meet budgetary specifications.

Key Responsibilities:

• Manage technical aspects of designated client projects

• Lead high-complexity submissions, including CTD Module 2

• Deliver clear and accurate regulatory documents

• Collaborate with Project Management on budget reviews

Requirements:

• Degree in Life Science or related field

• 5+ years of experience in Regulatory Writing

• Experience with CTD Module 2 submissions

• Proven track record as a Senior Regulatory Writer

Bring your expertise in regulatory documentation and project management to drive success at Apsida Life Science.
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