Sr. Manager/Associate Director, Regulatory Writer

Angitia Incorporated Limited

20d•$140,000 - $170,000

About The Position

The Senior Manager/Associate Director, Regulatory Writing will lead regulatory writing across Angitia's development portfolio, planning, authoring, coordinating, and delivering high-quality regulatory documents for global development programs from IND through marketing applications and lifecycle management. The role provides strategic document leadership in partnership with Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, CMC, and external partners, producing clear, scientifically rigorous, submission-ready documentation. The position establishes document standards and best practices, manages timelines, and ensures consistent, inspection-ready content across regulatory deliverables. As a key member of cross-functional development teams, this individual serves as the primary writing lead for major regulatory submissions and health authority interactions. Angitia is a clinical-stage biotechnology company established in June 2018. It focuses on discovering and developing therapeutics for serious musculoskeletal diseases and is studying two biologic product candidates for osteoporosis and osteogenesis imperfecta. The company has headquarters in Westlake Village, California, and offices in Guangzhou, China.

Requirements

Bachelor's degree in life sciences or a related discipline.
At least 10 years of medical writing or regulatory writing experience in 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, and health authority responses.
Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), FDA, EMA, and international regulatory requirements.
Ability to independently manage multiple complex writing projects simultaneously.
Experience leading cross-functional teams through document development and review cycles.

Nice To Haves

Advanced degree (PhD, PharmD, MD, or 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 Chinese proficiency.

Responsibilities

Lead strategic document planning for global regulatory submissions and health authority interactions.
Serve as lead writer for protocols and amendments, Investigator's Brochures, Clinical Study Reports, briefing packages, INDs, CTAs, Orphan Drug Designation applications, PIPs, PSPs, annual reports, development updates, and responses to health authority questions.
Develop integrated document strategies to 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 with Regulatory Affairs on 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 organizational writing capabilities.
Coordinate document finalization and publishing for major submissions.
Ensure compliance with ICH, FDA, EMA, PMDA, and other applicable regulatory requirements.
Support preparation for regulatory meetings and agency interactions.