Sr. Manager/Associate Director, Regulatory Writer

Role Overview:

• Lead the development and delivery of high-quality scientific and regulatory documentation across global clinical development programs.
• Oversee document strategy, author complex regulatory submissions, and coordinate cross-functional contributors.
• Mentor writers, manage external vendors, and improve processes to support efficient document delivery.

Key Accountabilities:

• Plan, author, and deliver regulatory documents for health authority interactions and marketing applications.
• Serve as lead author for protocols, IBs, CSRs, briefing packages, INDs, CTAs, and health authority responses.
• Establish writing standards, templates, and procedures to ensure consistency and inspection readiness.

Requirements:

• Bachelor's degree in life sciences and at least 10 years of medical/regulatory writing experience.
• Strong knowledge of ICH guidelines, GCP, FDA, EMA, and international regulatory standards.
• Proven ability to manage multiple complex writing projects and lead cross-functional teams.

Benefits:

• Medical, dental, and vision insurance; 401(k) with company matching.
• Paid time off, holidays, remote work stipend, and work-from-home equipment reimbursement.
• Company-paid disability, life insurance, and Employee Assistance Program.