Senior Regulatory Writing Lead - Global Submissions, Remote

Angitia Incorporated Limited; Westlake Village (CA); Remote; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

401K Retirement Plan with Companymatch

Company paid Long Term Disability

Company-paid life Insurance & AD&D

Voluntary Life Insurance & AD&D

Employee Assistance Program (EAP)

Company-paid Holidays

Vacation

Paid Sick Leave

Telecommunication Monthly Stipend

Work-From-Home Equipment Reimbursement

Job summary

Angitia Incorporated Limited is seeking a Senior Manager/Associate Director, Regulatory Writing to lead regulatory writing across its development portfolio for global submissions from IND through marketing application. This remote role involves planning, authoring, coordinating, and delivering high-quality documentation with cross-functional teams.

The ideal candidate has 10+ years in medical/regulatory writing, expert knowledge of ICH/GCP, and experience managing external vendors and major

Qualifications

• Bachelor's degree in life sciences or related discipline.
• 10+ years of medical/regulatory writing experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience serving as lead writer for major regulatory documents.
• Strong knowledge of ICH guidelines, GCP, FDA, EMA, and international regulatory requirements.

Responsibilities

• Lead the development of strategic document plans supporting global regulatory submissions and health authority interactions.
• Serve as lead writer for complex regulatory documents including protocols, IBs, CSRs, briefing packages, INDs/CTAs, and health authority responses.
• Develop integrated document strategies ensuring consistency across regulatory content.
• Lead document planning and review meetings with cross-functional teams.

Skills

Regulatory writing leadership

Clinical regulatory experience

Cross-functional collaboration

Mentoring writers

Vendor management

Education

Bachelor's degree in life sciences

Job description

Angitia Incorporated Limited is seeking a Senior Manager/Associate Director, Regulatory Writing to lead regulatory writing across its development portfolio for global submissions from IND through marketing application. This remote role involves planning, authoring, coordinating, and delivering high-quality documentation with cross-functional teams.

The ideal candidate has 10+ years in medical/regulatory writing, expert knowledge of ICH/GCP, and experience managing external vendors and major