Remote Regulatory Writing Lead – Global Submissions

OpenKrill; United States; Remote; USD 140,000 - 170,000; Full time

Benefits offered by this job

Remote work within US

Travel up to 20%

Medical coverage

401(k) plan

EAP

Job summary

OpenKrill seeks a Sr. Manager/Associate Director, Regulatory Writer to lead global regulatory documentation. Remote role in the United States, overseeing strategies, authoring complex submissions, and coordinating cross-functional teams from development through lifecycle management.

Ideal candidate has 10+ years in medical/regulatory writing, strong ICH/GCP knowledge, and proven ability to manage multiple submissions while mentoring writers and coordinating vendors.

Qualifications

• Strong regulatory writing background across biotech/pharma/CRO environments.
• Lead author experience for major regulatory submissions (IND/CTA/APPs).
• Deep knowledge of ICH, GCP, FDA and EMA standards.
• Demonstrated ability to manage multiple complex writing projects.
• Experience mentoring writers and coordinating vendors.

Responsibilities

• Lead planning, authoring, coordination, and delivery of regulatory documents.
• Develop strategic document plans aligned with milestones and timelines.
• Coordinate cross-functional reviews and subject-matter expert input.
• Mentor junior writers and manage external vendors as needed.
• Ensure submissions meet regulatory expectations and inspection readiness.

Skills

Regulatory writing

Lead writer

Cross-functional collaboration

Editorial oversight

Documentation strategy

Education

Bachelor's degree in life sciences

Job description

OpenKrill seeks a Sr. Manager/Associate Director, Regulatory Writer to lead global regulatory documentation. Remote role in the United States, overseeing strategies, authoring complex submissions, and coordinating cross-functional teams from development through lifecycle management.

Ideal candidate has 10+ years in medical/regulatory writing, strong ICH/GCP knowledge, and proven ability to manage multiple submissions while mentoring writers and coordinating vendors.