Sr. Manager/Associate Director, Regulatory Writer

We are seeking an experienced regulatory writing professional to lead the development and delivery of high-quality scientific and regulatory documentation across global clinical development programs. In this remote role, you will oversee document strategy, author complex regulatory submissions, and coordinate cross-functional contributors to support programs from initial clinical development through marketing applications and lifecycle management. You will partner with experts across Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, and Chemistry, Manufacturing, and Controls (CMC) to ensure scientific accuracy and regulatory compliance. As the primary writing lead for major submissions and health authority interactions, you will establish best practices, strengthen document quality, and maintain submission readiness. You will also mentor writers, manage external vendors, and improve processes that support efficient, consistent document delivery. This is an opportunity to influence global development strategies and contribute to advancing innovative therapies for patients with significant unmet medical needs.

• Bachelor's degree in life sciences or a related scientific discipline.

• At least 10 years of medical writing or regulatory writing experience within biotechnology, pharmaceutical, or contract research organization (CRO) environments.

• Demonstrated experience serving as lead writer for major regulatory documents and submissions.

• Extensive hands-on experience authoring and coordinating clinical protocols, Investigator’s Brochures, Clinical Study Reports, regulatory briefing documents, IND and CTA submissions, and responses to health authority questions.

• Strong knowledge of ICH guidelines, Good Clinical Practice, FDA and EMA requirements, and international regulatory standards.

• Proven ability to independently manage multiple complex writing projects simultaneously while maintaining scientific quality, regulatory compliance, and delivery timelines.

• Experience leading cross-functional teams through document planning, development, review, and finalization.

• Excellent scientific writing, editing, analytical, and organizational skills, with strong attention to detail and consistency.

• Strong communication and stakeholder management skills, including the ability to facilitate technical discussions, resolve content disagreements, and align multidisciplinary teams.

• Ability to establish effective writing processes, manage competing priorities, and exercise sound judgment in a dynamic development environment.

Preferred Qualifications:

• Advanced degree in a scientific discipline, such as a PhD, PharmD, MD, or MS.

• Certification from the American Medical Writers Association (AMWA).

• Experience supporting Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), or New Drug Applications (NDAs).

• Experience in rare disease and pediatric drug development programs.

• Experience supporting biologics development.

• Experience managing external medical writing vendors, consultants, and contract writers.

• Bilingual proficiency in English and Chinese.