Sr. Manager/Associate Director, Regulatory Writer (Fully Remote)

Jobgether; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Jobgether in the United States is seeking a senior Regulatory Affairs Writer to lead the planning, drafting, and delivery of regulatory documents for global development programs and health authority interactions.

You will develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance, coordinate cross-functional teams, manage external vendors, and mentor junior writers to maintain submission readiness across

Responsibilities

• Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
• Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
• Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.

Job description

• Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
• Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
• Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.