Regulatory Affairs Manager - INDs/NDAs & Equity Eligible

BeiGene Ltd.; United States; Remote; USD 122,000 - 162,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. is seeking an experienced Regulatory Affairs Manager to plan, coordinate, and complete regulatory submissions across US and international sites.

The role involves leading authoring efforts, providing regulatory strategy guidance, and representing Regulatory Affairs on cross-functional teams. The candidate will manage INDs, BLAs/NDAs and amendments, ensure compliance with FDA/ICH guidance, and stay current on regulatory developments.

Qualifications

• 5+ years’ related experience with a BA/BS degree is required.
• Experience with INDs and NDAs, CTD/eCTD familiarity.
• Working knowledge of FDA and ICH guidance and GMP/GCP concepts.
• Ability to author and coordinate regulatory submissions and dossiers.

Responsibilities

• Plan and manage regulatory activities spanning clinical, non-clinical, and CMC.
• Develop strategies for early approvals/clearance of submissions.
• Lead preparation and submission of INDs, BLAs/NDAs, amendments, and annual reports.
• Ensure compliance, manage meetings and briefing documents, and maintain regulatory archives.
• Collaborate with CROs/consultants and cross-functional teams on regulatory matters.

Skills

Regulatory strategy

Cross-functional leadership

Attention to detail

Planning

Communication

Education

BA/BS degree

Tools

Adobe Acrobat Pro

Job description

BeOne Medicines Ltd. is seeking an experienced Regulatory Affairs Manager to plan, coordinate, and complete regulatory submissions across US and international sites.

The role involves leading authoring efforts, providing regulatory strategy guidance, and representing Regulatory Affairs on cross-functional teams. The candidate will manage INDs, BLAs/NDAs and amendments, ensure compliance with FDA/ICH guidance, and stay current on regulatory developments.