Sr. Manager/Associate Director, Regulatory Writer

📋 Description

• Lead the planning, authoring, coordination, and delivery of regulatory documents supporting global
• Develop strategic document plans aligned with regulatory milestones, submission timelines, and
• Serve as the lead author for complex regulatory documents, including clinical protocols and
• Prepare and coordinate additional regulatory deliverables, including Orphan Drug Designation
• Integrate scientific and clinical information across regulatory, clinical, nonclinical, safety, and
• Lead cross-functional document planning, review meetings, and content discussions, aligning subject

🎯 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
• Demonstrated experience serving as lead writer for major regulatory documents and submissions.
• Extensive hands-on experience authoring and coordinating clinical protocols, Investigator's
• Strong knowledge of ICH guidelines, Good Clinical Practice, FDA and EMA requirements, and
• Proven ability to independently manage multiple complex writing projects simultaneously while

🎁 Benefits

• Annual salary: $140,000–$170,000.
• Remote work: Work remotely within the United States, with a preference for candidates working in
• 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.