Principal Regulatory Writer

Position: Principal Regulatory Writer Apsida Life Science
Elevate your career with Apsida Life Science as a Principal Regulatory Writer. With a focus on high-complexity submissions, this role offers a 0.8 FTE model and the chance to shape projects across diverse therapeutic areas.

Apsida Life Science collaborates with a leading regulatory writing consultancy to expand its reach in North America. This position requires strong leadership for client accounts, ensuring technical accuracy in regulatory documents. You will contribute your expertise in CTD Module 2 submissions and support project budgets, all within a team-oriented culture.

Key Responsibilities:

• Manage project deliverables for designated client accounts

• Lead high-complexity submissions including CTD Module 2

• Ensure clarity and accuracy in regulatory documents

• Provide technical guidance and scientific expertise

• Assist project management with budget development and review

Requirements:

• Degree in Life Science or relevant field

• 5+ years in Regulatory Writing experience

• Expertise in authoring CTD Module 2 submissions

• Proven record as a Senior/Principal Regulatory Writer

• Strong technical and scientific writing skills

Become an essential part of a team committed to scientific excellence and strategic impact at Apsida Life Science.
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