Senior Regulatory Writing Lead — Remote

Angitia Biopharmaceuticals; Los Angeles (CA); Remote; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Long Term Disability

Life Insurance

Voluntary Life Insurance

Employee Assistance Program (EAP)

Paid Holidays

Vacation

Sick Leave

Telecommunication stipend

Home office equipment reimbursement

Job summary

Angitia Biopharmaceuticals seeks a Sr. Manager/Associate Director, Regulatory Writing, to lead writing across its development programs from IND through lifecycle management.

You will plan, author, coordinate, and deliver submission-ready documents with strict timelines and high scientific standards. This role partners with Regulatory Affairs, Clinical Development, Biostatistics, Safety, and CMC, mentoring junior writers and managing external vendors while ensuring compliance with ICH, FDA, EMA

Qualifications

• Bachelor's degree in life sciences or related discipline.
• Minimum 10 years of medical writing or regulatory writing experience.
• Lead writer experience for major regulatory documents (INDs, CTAs, CSRs, IBs).
• Extensive knowledge of ICH, GCP, FDA/EMA regulatory requirements.
• Ability to manage multiple complex writing projects and lead cross-functional teams.

Responsibilities

• Lead strategic document plans for global regulatory submissions and health authority interactions.
• Serve as lead writer for complex documents: IBs, CSRs, protocols, INDs/CTAs, PIPs/PSPs, annual reports, responses to questions.
• Develop integrated document strategies ensuring consistency across clinical, nonclinical, safety, and CMC content.
• Lead document planning and review meetings with cross-functional teams.
• Mentor junior writers and manage external writing vendors as needed.
• Coordinate finalization and publishing for major submissions; ensure inspection-ready content.

Skills

Regulatory writing leadership

Cross-functional collaboration

Project management

ICH/GCP knowledge

Education

Bachelor's degree in life sciences

Job description

Angitia Biopharmaceuticals seeks a Sr. Manager/Associate Director, Regulatory Writing, to lead writing across its development programs from IND through lifecycle management.

You will plan, author, coordinate, and deliver submission-ready documents with strict timelines and high scientific standards. This role partners with Regulatory Affairs, Clinical Development, Biostatistics, Safety, and CMC, mentoring junior writers and managing external vendors while ensuring compliance with ICH, FDA, EMA