Senior Regulatory Writing Lead — Remote

Angitia Bio; Westlake Village (CA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision

401(K) retirement

Long term disability

Life Insurance & AD&D

Voluntary life insurance

Employee Assistance Program

Company holidays

Vacation

Paid sick leave

Telecommunication stipend

Work-from-home equipment

Job summary

Angitia Bio is seeking a Senior Manager/Associate Director of Regulatory Writing to lead global regulatory documentation from IND to marketing approval. Remote role with up to 20% travel, reporting to the Executive Director, Global Regulatory Affairs.

You will plan, author, and coordinate submission-ready documents, establish standards, and mentor junior writers across cross-functional teams to ensure inspection-ready content.

Qualifications

• Bachelor's degree in life sciences or related discipline.
• 10+ years of medical writing or regulatory writing experience in biotech, pharma, or CROs.
• Experience serving as lead writer for major regulatory documents.
• Extensive experience authoring and coordinating protocols, IBs, CSRs, regulatory briefs, IND/CTA submissions, health authority responses.
• Strong knowledge of ICH, GCP, FDA/EMA and international requirements.
• Able to manage multiple complex writing projects and lead cross-functional teams.

Responsibilities

• Lead strategic document plans for global regulatory submissions and health authority interactions.
• Be the lead writer for regulatory documents (protocols, IBs, CSRs, briefs, INDs/CTAs, responses).
• Develop integrated document strategies across regulatory, clinical, nonclinical, safety and CMC content.
• Lead planning and review meetings with cross-functional teams.
• Mentor junior writers and manage external vendors as needed.
• Coordinate finalization and publishing for major submissions.
• Ensure compliance with ICH, FDA, EMA and other requirements.

Skills

Regulatory writing

Cross-functional leadership

Regulatory submissions

ICH Guidelines

Project management

Education

Bachelor's degree in life sciences

Tools

AMWA certification

FDA/EMA knowledge

Job description

Angitia Bio is seeking a Senior Manager/Associate Director of Regulatory Writing to lead global regulatory documentation from IND to marketing approval. Remote role with up to 20% travel, reporting to the Executive Director, Global Regulatory Affairs.

You will plan, author, and coordinate submission-ready documents, establish standards, and mentor junior writers across cross-functional teams to ensure inspection-ready content.