Senior Manager/Associate Director, Regulatory Writer

Angitia Biopharmaceuticals

. Lead the development of strategic document plans supporting global regulatory submissions and health authority interactions .

Posted 10/20/2026full-timeRemote • California • United StatesSenior💰 $140,000 - $170,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory writing and document development for global submissions, with a strong focus on compliance with ICH, FDA, and EMA guidelines. Proven ability to lead cross-functional teams and mentor junior writers while managing complex writing projects effectively.

Highest-signal resume keywords

Regulatory Writing ExperienceLead Writer for Major Regulatory DocumentsKnowledge of ICH GuidelinesBilingual English and Chinese ProficiencyAMWA Certification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Medical WritingProtocol DevelopmentClinical Study ReportsIND SubmissionsCTA SubmissionsRegulatory Briefing DocumentsDocument Quality ManagementDocument Development StandardsSubmission ReadinessBiologics Development

Soft Skills

MentoringCross-Functional Team LeadershipProject ManagementCommunicationProblem Solving

Certifications & Qualifications

AMWA Certification

Industry Keywords

BiotechnologyPharmaceuticalCROGCPBLAMAANDARare DiseasePediatric DevelopmentHealth Authority Interactions

About the role

Key responsibilities & impact

Lead the development of strategic document plans supporting global regulatory submissions and health authority interactions
Serve as lead writer for protocols, protocol amendments, Investigator's Brochures, Clinical Study Reports, briefing packages, INDs and CTAs, Orphan Drug Designation applications, Pediatric Investigation Plans, Pediatric Study Plans, annual reports, development updates, and responses to health authority questions
Develop integrated document strategies 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 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
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 activities for major submissions
Ensure compliance with ICH, FDA, EMA, PMDA, and other applicable regulatory requirements
Support preparation for regulatory meetings and agency interactions

Requirements

What you’ll need

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, and 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
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 Chinese proficiency

Benefits

Comp & perks

Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement