Sr. Manager/Associate Director, Regulatory Writer

What you'll do

• Plan and lead writing, review, and delivery of regulatory documents, including INDs, CTAs, protocols, Investigator’s Brochures, Clinical Study Reports, and agency responses.
• Coordinate cross-functional document teams, timelines, vendors, and submission finalization; maintain writing standards and processes.
• Partner with Regulatory Affairs on submission strategy and health authority interactions, ensuring documents meet applicable regulatory requirements.

What they ask for

• Bachelor’s degree in life sciences or a related discipline.
• At least 10 years of medical or regulatory writing experience in biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience as lead writer for major regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, briefing documents, INDs/CTAs, and health authority responses.
• Strong knowledge of ICH guidelines, GCP, FDA, EMA, and international regulatory requirements; ability to manage multiple complex projects and lead cross-functional document teams.

Nice to have

• Advanced scientific degree; AMWA certification; experience supporting BLA, MAA, or NDA submissions.
• Experience in rare disease, pediatric, or biologics development; vendor management; bilingual English and Chinese proficiency.

Pay

$140K to 170K (USD; salary range; base salary or total pay not specified)

Tools

ICH, Good Clinical Practice (GCP), FDA, EMA, PMDA