Global Regulatory Affairs Manager – Submissions & Strategy

Regulatory Jobs; United States; Remote; USD 122,000 - 162,000; Full time

Job summary

BeOne Medicines Ltd. seeks an experienced Regulatory Manager to plan, coordinate, and complete regulatory submissions across US and international markets.

You will lead cross-functional teams, guide regulatory strategy, and ensure timely IND/ANDA filings, amendments, and annual reports, while maintaining compliance with FDA and ICH guidelines. The role requires 5+ years in regulatory affairs, CTD/eCTD proficiency, and strong communication skills.

Qualifications

• 5+ years of regulatory affairs experience with a BA/BS degree.
• Experience preparing INDs and NDAs; CTD/eCTD familiarity.
• Proficiency with FDA/ICH guidance and regulations.
• Experience with Adobe Acrobat Pro for document publishing.
• Understanding regulatory requirements across regions.
• Excellent verbal and written communication and strong planning skills.

Responsibilities

• Plan and manage regulatory activities across clinical, non-clinical, and CMC.
• Develop strategies for earliest approvals/clearances.
• Prepare, assemble, review, and submit regulatory dossiers worldwide.
• Ensure compliance and manage meetings/briefing documents.
• Prepare, review, and submit INDs, NDAs and supplements.
• Maintain regulatory knowledge and coordinate with external consultants.

Skills

Regulatory planning

Cross-functional collaboration

Regulatory strategy

Education

BA/BS degree

Tools

Adobe Acrobat Pro

Job description

BeOne Medicines Ltd. seeks an experienced Regulatory Manager to plan, coordinate, and complete regulatory submissions across US and international markets.

You will lead cross-functional teams, guide regulatory strategy, and ensure timely IND/ANDA filings, amendments, and annual reports, while maintaining compliance with FDA and ICH guidelines. The role requires 5+ years in regulatory affairs, CTD/eCTD proficiency, and strong communication skills.