Senior Manager/Associate Director, Regulatory Writer

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the creation of strategic document plans that support global regulatory submissions and interactions with health authorities.

• Act as the primary 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 inquiries from health authorities.

• Formulate integrated document strategies covering regulatory, clinical, nonclinical, safety, and CMC content.

• Direct document planning and review meetings with cross-functional project teams.

• Facilitate alignment among subject matter experts and address content issues to ensure adherence to timelines and maintain document quality.

• Collaborate with Regulatory Affairs to bolster global regulatory strategies and agency interactions.

• Represent Regulatory Writing in project teams and governance meetings.

• Create and uphold writing processes, templates, style guides, and standards for document development.

• Enhance writing workflows and ensure submission readiness.

• Oversee external medical writing vendors and contract writers as necessary.

• Mentor junior writers and enhance the organization's writing capabilities.

• Coordinate the finalization and publishing activities for significant submissions.

• Ensure compliance with ICH, FDA, EMA, PMDA, and other relevant regulatory standards.

• Assist in preparation for regulatory meetings and agency interactions.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field.

• At least 10 years of experience in medical writing or regulatory writing within biotechnology, pharmaceutical, or CRO settings.

• Proven experience serving as the lead writer for major regulatory documents.

• Extensive background in authoring and coordinating protocols, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, IND and CTA submissions, and responses to health authority inquiries.

• Strong understanding of ICH guidelines, Good Clinical Practice (GCP), FDA, EMA, and international regulatory requirements.

• Demonstrated capacity to independently manage multiple complex writing projects at the same time.

• 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.

• Background in rare disease and pediatric development programs.

• Experience in supporting biologics development.

• Experience managing external writing vendors and consultants.

• Proficiency in both English and Chinese.

🏝️ Benefits

• 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.