Senior Regulatory Writing Director - Remote (PST)

Jobgether; États-Unis; À distance; USD 140 000 - 170 000; Plein temps

Avantages offerts par ce poste

Remote work within the United States (

Domestic travel up to 20%

Medical, dental, and vision insurance

401(k) retirement plan with company 2%

Company-paid long-term disability

Company-paid life insurance

Employee Assistance Program (EAP)

Paid holidays and paid time off

Home office stipend and equipment

Résumé du poste

Jobgether is seeking a Sr. Manager/Associate Director, Regulatory Writing in the United States to lead the development of regulatory documents across global programs. This remote role requires coordinating cross-functional teams, mentoring writers, and ensuring submission readiness.

You will serve as lead author for major submissions, manage external vendors, and drive writing standards in alignment with ICH, GCP, FDA, and EMA requirements to advance innovative therapies.

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years medical or regulatory writing experience in biotech/pharma/CRO.
• Experience leading authoring for major regulatory documents and submissions.
• Strong knowledge of ICH, GCP, FDA/EMA standards.
• Ability to manage multiple complex projects and timelines.
• Experience leading cross-functional teams through planning, development, review and finalization.

Responsabilités

• Lead planning, authoring, coordination, and delivery of regulatory documents for global development programs and health authority interactions.
• Develop strategic document plans aligned with regulatory milestones and submission timelines.
• Lead authoring for protocols, IBs, CSRs, briefing packages, IND/CTA submissions, and health authority responses.
• Coordinate additional deliverables including Orphan Drug Designations, PIPs, PSPs, annual reports, and updates.
• Integrate information across regulatory, clinical, nonclinical, safety, and CMC functions for consistency and accuracy.
• Lead cross-functional document planning, reviews, and content discussions with SMEs.
• Collaborate with Regulatory Affairs leadership on global strategy and submissions planning.
• Represent Regulatory Writing in project teams and governance meetings; communicate status and risks.
• Establish writing standards, templates, style guides, and development procedures.
• Identify opportunities to improve workflows, review cycles, and submission readiness.
• Manage external vendors and contract writers to ensure quality and timelines.
• Mentor junior writers and contribute to capability development.
• Coordinate finalization and publishing activities for major submissions.
• Ensure alignment with ICH, GCP, FDA, EMA and other international requirements.

Connaissances

Regulatory writing leadership

Clinical development knowledge

Cross-functional collaboration

Mentoring/writing leadership

Vendor management

Formation

Bachelor's degree in life sciences

Advanced degree preferred

AMWA certification preferred

Outils

External medical writing vendors

Description du poste

Jobgether is seeking a Sr. Manager/Associate Director, Regulatory Writing in the United States to lead the development of regulatory documents across global programs. This remote role requires coordinating cross-functional teams, mentoring writers, and ensuring submission readiness.

You will serve as lead author for major submissions, manage external vendors, and drive writing standards in alignment with ICH, GCP, FDA, and EMA requirements to advance innovative therapies.