Position: Regulatory Writer (Sr. Manager/Associate Director)
Department: Development – Regulatory Affairs
Location: Remote (PST Zone) with occasional travel for team and client meetings
Reports To: Executive Director, Global Regulatory Affairs
P osition Summary
The Senior Manager/Associate Director, Regulatory Writing will serve as the lead regulatory writing professional across Angitia's development portfolio and will be responsible for planning, authoring, coordinating, and delivering high-quality regulatory documents supporting global development programs from IND through marketing application and lifecycle management activities. This individual will provide strategic document leadership, working closely with Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, CMC, and external partners to develop clear, scientifically rigorous, and submission-ready documentation. The role will establish document standards and best practices, manage document timelines, and ensure consistent, inspection-ready content across all regulatory deliverables. The successful candidate will function as a key member of cross-functional development teams and serve as the primary writing lead for major regulatory submissions and health authority interactions.
R e sponsibilities
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 and protocol amendments
Investigator's Brochures (IBs)
Clinical Study Reports (CSRs)
Briefing packages
INDs and CTAs
Orphan Drug Designation applications
Pediatric Investigation Plans (PIPs)
Pediatric Study Plans (PSPs)
Annual reports and development updates
Responses to health authority questions
Develop integrated document strategies that ensure consistency across regulatory, clinical, nonclinical, safety, and CMC content.
Lead document planning and review meetings with cross-functional project teams.
Facilitate alignment among subject matter experts and resolve content issues to maintain timelines and document quality.
Partner closely with Regulatory Affairs to support global regulatory strategies and agency interactions.
Represent Regulatory Writing on project teams and governance meetings.
Develop and maintain writing processes, templates, style guides, and document development standards.
Identify opportunities to improve writing workflows and submission readiness.
Manage external medical writing vendors and contract writers as needed.
Mentor junior writers and contribute to development of organizational writing capabilities.
Coordinate document finalization and publishing activities for major submissions.
Ensure compliance with ICH, FDA, EMA, PMDA, and other applicable regulatory requirements.
Support preparation for regulatory meetings and agency interactions.
Q ualifications
Bachelor's degree in life sciences or related discipline.
Minimum 10 years of medical writing or regulatory writing experience within biotechnology, pharmaceutical, or CRO environments.
Demonstrated experience serving as lead writer for major regulatory documents.
Extensive experience authoring and coordinating:
Protocols
Investigator's Brochures
Clinical Study Reports
Regulatory briefing documents
IND and CTA submissions
Health authority responses
Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), FDA, EMA, and international regulatory requirements.
Demonstrated ability to independently manage multiple complex writing projects simultaneously.
Experience leading cross-functional teams through document development and review cycles.
Preferred
Advanced degree (PhD, PharmD, MD, MS) in a scientific discipline.
AMWA certification.
Experience supporting BLA, MAA, or NDA submissions.
Experience in rare disease and pediatric development programs.
Experience supporting biologics development.
Experience managing external writing vendors and consultants.
Bilingual English and…