Senior Regulatory Affairs Manager — Submissions Lead

Regulatory Jobs; United States; Remote; USD 140,000 - 185,000; Full time

Job summary

BeOne Medicines Ltd. in the United States is seeking an experienced Regulatory Affairs Manager to oversee planning, evaluating, and completing regulatory submissions across clinical, non-clinical, and CMC areas.

You will lead cross-functional teams, author dossiers for US and international submissions, ensure compliance with FDA guidance and CTD/eCTD, and mentor staff in a fast-paced, entrepreneurial setting.

Qualifications

• 7+ years’ related experience with a BA/BS degree.
• Experience with INDs (required) and NDAs (desirable), plus amendments and supplements.
• Experience with CTD/eCTD and regulatory publishing tools.
• Working knowledge of FDA guidance, ICH regulations, GMP/GLP/GCP.

Responsibilities

• Plan and manage regulatory activities across clinical, non-clinical and CMC.
• Develop strategies for earliest approvals/clearances of regulatory submissions.
• Prepare, write and submit regulatory dossiers for US and international registrations.
• Maintain submissions in compliance and manage briefing documents and meetings.
• Lead cross-functional teams and coordinate with CROs/consultants on regulatory matters.

Skills

Regulatory strategy

Project management

FDA regulations

CTD/eCTD

Adobe Acrobat

Communication

Leadership

GMP/GLP/GCP

Education

BA/BS degree

Tools

Adobe Acrobat Professional

Job description

BeOne Medicines Ltd. in the United States is seeking an experienced Regulatory Affairs Manager to oversee planning, evaluating, and completing regulatory submissions across clinical, non-clinical, and CMC areas.

You will lead cross-functional teams, author dossiers for US and international submissions, ensure compliance with FDA guidance and CTD/eCTD, and mentor staff in a fast-paced, entrepreneurial setting.