Regulatory Affairs Manager - Submissions & Strategy Lead

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

BeOne Medicines Ltd. seeks an experienced Regulatory Affairs Manager to lead planning, evaluation, and submission activities across clinical, non-clinical, and CMC programs.

You will guide cross-functional teams on regulatory strategy and tactics, and represent Regulatory Affairs on project teams. The role focuses on timely IND/NDAs submissions, maintains compliance with FDA/ICH guidelines, and coordinates with CROs while staying current on regulatory developments that impact product life cycles

Qualifications

• 5+ years’ related experience with a BA/BS degree is required.
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements.
• Experience with CTD/eCTD.
• Experience with publishing documents in Adobe Acrobat Professional.
• Working knowledge of FDA and ICH regulatory guidance and regulations.

Responsibilities

• Plan and manage regulatory activities spanning clinical, non-clinical, and CMC.
• Assist in developing strategies for earliest possible approvals/clearance.
• Manage preparation and timely submission of regulatory dossiers for US and abroad.
• Ensure compliance with regulatory requirements and support meeting requests/briefing docs.
• Prepare, review, and submit INDs, NDAs, amendments and supplements; advise project teams.
• Maintain regulatory knowledge and coordinate with external consultants/CROs.

Skills

Regulatory submissions planning

Cross-functional collaboration

Regulatory strategy guidance

FDA/ICH regulatory knowledge

Adobe Acrobat Pro documentation

Education

BA/BS degree

Tools

CTD/eCTD experience

Adobe Acrobat Professional

Job description

BeOne Medicines Ltd. seeks an experienced Regulatory Affairs Manager to lead planning, evaluation, and submission activities across clinical, non-clinical, and CMC programs.

You will guide cross-functional teams on regulatory strategy and tactics, and represent Regulatory Affairs on project teams. The role focuses on timely IND/NDAs submissions, maintains compliance with FDA/ICH guidelines, and coordinates with CROs while staying current on regulatory developments that impact product life cycles