Principal Regulatory Writer

Position: Principal Regulatory Writer or US
Step into a leading role at Apsida Life Science as a Principal Regulatory Writer. This pivotal position supports high-complexity projects in regulatory writing across the North American pharmaceutical market.

Join a well-established consultancy renowned for its scientific excellence and strategic expertise. As a Principal Regulatory Writer, you will manage client accounts, lead regulatory submissions like CTD Module 2, and deliver high-quality, accurate documentation that meets client needs. This role can accommodate a 0.8

FTE working model for added flexibility.

Key Responsibilities:

• Manage technical aspects of designated client accounts

• Lead strategic submissions, including CTD Module 2

• Ensure accuracy and transparency in written documents

• Collaborate with Project Management on budget reviews

Requirements:

• Degree in Life Science or related area

• 5+ years of experience in Regulatory Writing

• Experience in CTD Module 2 submissions, sections 2.7.3 and 2.7.4

• Proven Senior/Principal Regulatory Writing expertise

Elevate your career by contributing to Apsida Life Science's impactful projects in regulatory writing.
#J-18808-Ljbffr