Leading Principal Regulatory Writer Role
Apsida Life Science
Become a vital contributor as a Principal Regulatory Writer for key projects across North America. In this role, leverage your expertise in regulatory writing focused on CTD Module 2 submissions with a flexible 0.8 FTE work model. This position is ideal for experienced writers skilled in managing technical aspects of designated client accounts. You will lead complex programs requiring high-level strategic input, ensuring document accuracy and clarity. Collaborate closely with the Project Management team to align budgets and project specifications effectively. Key Responsibilities:
- Serve as point of contact for project deliverables
- Lead complex programs and submissions for CTD Module 2
- Ensure high-quality, accurate regulatory documents
- Support budget development and review against specifications
- Provide technical guidance throughout project lifecycle
- Degree in Life Science or relevant field
- Minimum 5 years of regulatory writing experience
- Experience with CTD Module 2 submissions
- Proven track record as a Senior/Principal Regulatory Writer
- Strong technical and scientific writing skills
Vacancy posted 2 hours ago
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