About the company
Position listed on behalf of a partner company managing all applications. The partner is seeking a Sr. Manager/Associate Director, Regulatory Writer based in the United States.
Responsibilities
- Lead planning, authoring, coordination, and delivery of regulatory documents supporting global development programs, health authority interactions, and marketing applications
- Develop strategic document plans aligned with regulatory milestones and submission timelines
- Serve as lead author for clinical protocols and amendments, Investigator's Brochures, Clinical Study Reports, briefing packages, IND applications, CTAs, and health authority responses
- Prepare Orphan Drug Designation applications, PIPs, PSPs, annual reports, and development updates
- Integrate scientific and clinical information across regulatory, clinical, nonclinical, safety, and CMC functions
- Lead cross-functional document planning, review meetings, and content discussions
- Collaborate with Regulatory Affairs leadership on global regulatory strategies
- Establish and maintain writing standards, templates, style guides, and document development procedures
- Manage external medical writing vendors and contract writers
- Mentor junior writers
- Ensure alignment with ICH guidelines, GCP, and FDA, EMA, PMDA requirements
Requirements
- Bachelor's degree in life sciences or related scientific discipline
- At least 10 years of medical writing or regulatory writing experience in biotech, pharma, or CRO
- Demonstrated experience as lead writer for major regulatory documents and submissions
- Hands-on experience with clinical protocols, IBs, CSRs, briefing documents, IND and CTA submissions, and health authority responses
- Strong knowledge of ICH guidelines, GCP, FDA and EMA requirements
- Ability to manage multiple complex writing projects simultaneously
- Experience leading cross-functional teams through document planning and finalization
- Excellent scientific writing, editing, analytical, and organizational skills
- Preferred: advanced degree (PhD, PharmD, MD, MS), AMWA certification, experience with BLAs, MAAs, NDAs, rare disease and pediatric programs, biologics development, bilingual English/Chinese
Conditions
- Remote role based in the United States