Sr. Manager/Associate Director, Regulatory Writer

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Sr. Manager/Associate Director, Regulatory Writer based in the United States. We are seeking an experienced regulatory writing professional to lead the development and delivery of high-quality scientific and regulatory documentation across global clinical development programs. In this remote role, you will oversee document strategy, author complex regulatory submissions, and coordinate cross-functional contributors to support programs from initial clinical development through marketing applications and lifecycle management. You will partner with experts across Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, and Chemistry, Manufacturing, and Controls (CMC) to ensure scientific accuracy and regulatory compliance. As the primary writing lead for major submissions and health authority interactions, you will establish best practices, strengthen document quality, and maintain submission readiness. You will also mentor writers, manage external vendors, and improve processes that support efficient, consistent document delivery. This is an opportunity to influence global development strategies and contribute to advancing innovative therapies for patients with significant unmet medical needs.

Lead the planning, authoring, coordination, and delivery of regulatory documents supporting global development programs, health authority interactions, and marketing applications. Develop strategic document plans aligned with regulatory milestones, submission timelines, and broader clinical development objectives. Serve as the lead author for complex regulatory documents, including clinical protocols and amendments, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and health authority responses. Prepare and coordinate additional regulatory deliverables, including Orphan Drug Designation applications, Pediatric Investigation Plans (PIPs), Pediatric Study Plans (PSPs), annual reports, and development updates. Integrate scientific and clinical information across regulatory, clinical, nonclinical, safety, and CMC functions to ensure consistency, accuracy, and clarity throughout submission documentation. Lead cross-functional document planning, review meetings, and content discussions, aligning subject matter experts and resolving issues that could affect quality or timelines. Collaborate closely with Regulatory Affairs leadership to support global regulatory strategies, submission planning, and interactions with health authorities. Represent Regulatory Writing in project teams and governance meetings, communicating document status, risks, and recommendations to relevant stakeholders. Establish and maintain writing standards, templates, style guides, and document development procedures that promote consistency and inspection readiness. Identify opportunities to improve writing workflows, review cycles, submission preparation, and overall operational efficiency. Manage external medical writing vendors and contract writers, as needed, ensuring deliverables meet established quality standards and timelines. Mentor junior writers and contribute to the development of organizational regulatory writing capabilities. Coordinate document finalization and publishing activities for major submissions, ensuring compliance with applicable regulatory expectations. Ensure regulatory documents align with relevant ICH guidelines, Good Clinical Practice (GCP), and applicable FDA, EMA, PMDA, and other international requirements. Support preparation for regulatory meetings and agency interactions through clear, scientifically rigorous documentation. Requirements: Bachelor's degree in life sciences or a related scientific discipline. At least 10 years of medical writing or regulatory writing experience within biotechnology, pharmaceutical, or contract research organization (CRO) environments. Demonstrated experience serving as lead writer for major regulatory documents and submissions. Extensive hands-on experience authoring and coordinating clinical protocols, Investigator’s Brochures, Clinical Study Reports, regulatory briefing documents, IND and CTA submissions, and responses to health authority questions. Strong knowledge of ICH guidelines, Good Clinical Practice, FDA and EMA requirements, and international regulatory standards. Proven ability to independently manage multiple complex writing projects simultaneously while maintaining scientific quality, regulatory compliance, and delivery timelines. Experience leading cross-functional teams through document planning, development, review, and finalization. Excellent scientific writing, editing, analytical, and organizational skills, with strong attention to detail and consistency. Strong communication and stakeholder management skills, including the ability to facilitate technical discussions, resolve content disagreements, and align multidisciplinary teams. Ability to establish effective writing processes, manage competing priorities, and exercise sound judgment in a dynamic development environment. Preferred Qualifications: Advanced degree in a scientific discipline, such as a PhD, PharmD, MD, or MS. Certification from the American Medical Writers Association (AMWA). Experience supporting Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), or New Drug Applications (NDAs). Experience in rare disease and pediatric drug development programs. Experience supporting biologics development. Experience managing external medical writing vendors, consultants, and contract writers. Bilingual proficiency in English and Chinese. Benefits: Annual salary: $140,000–$170,000. Remote work: Work remotely within the United States, with a preference for candidates working in the Pacific Standard Time (PST) zone. Travel: Occasional domestic travel of up to 20% for team and client meetings. Medical coverage: Medical, dental, and vision insurance for employees and eligible dependents. Retirement savings: 401(k) retirement plan with company matching. Disability protection: Company-paid long-term disability coverage. Life insurance: Company-paid life insurance and accidental death and dismemberment (AD&D) coverage, with additional voluntary coverage available. Employee assistance: Access to an Employee Assistance Program (EAP). Paid holidays: Company-paid holidays. Paid time off: Vacation and paid sick leave. Remote work support: Monthly telecommunications stipend and reimbursement for work-from-home equipment. Professional impact: Opportunity to lead regulatory writing strategy and contribute to global clinical development and regulatory submissions. Leadership opportunities: Scope to mentor writers, improve organizational processes, and influence cross-functional development programs.