Regulatory Submissions Lead, FDA (IND/NDA/BLA)

BeOne Medicines Ltd.; United States; Remoto; USD 94.000 - 124.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Descrizione del lavoro

BeOne Medicines Ltd. is seeking a Senior Associate Regulatory Affairs to manage U.S. submissions (INDs, NDAs, BLAs) for investigational and commercial products. You will coordinate cross-functional teams, ensure FDA compliance, and drive submissions to on-time completion.

The ideal candidate has hands-on U.S. IND experience, proficiency with eCTD, and strong communication. BeOne offers a comprehensive benefits package and a path to equity, with a collaborative, fast-paced environment.

Competenze

• Hands-on experience with U.S. IND preparation.
• Experience with NDA/BLA submissions.
• Familiarity with FDA guidance and ICH regulations.

Mansioni

• Coordinate US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations.
• Draft regulatory submission documents (e.g., IND components) as required.
• Review regulatory documentation for accuracy, consistency, and completeness.
• Serve as primary execution lead and cross-functional coordinator for assigned submissions.
• Collaborate with Regulatory Strategy and cross-functional teams to gather submission-ready documents.
• Perform QC checks to ensure FDA submission readiness and document integrity.
• Maintain IND, NDA, BLA submission archives with version control.

Conoscenze

Regulatory systems (Veeva Vault BRIM)

MS Office suite (Word, Excel, PowerPo​

Submission timelines management

Cross-functional collaboration

Formazione

BA/BS degree in science or health-related discipline

Strumenti

Adobe Acrobat Pro

CTD/eCTD workflows

Descrizione del lavoro

BeOne Medicines Ltd. is seeking a Senior Associate Regulatory Affairs to manage U.S. submissions (INDs, NDAs, BLAs) for investigational and commercial products. You will coordinate cross-functional teams, ensure FDA compliance, and drive submissions to on-time completion.

The ideal candidate has hands-on U.S. IND experience, proficiency with eCTD, and strong communication. BeOne offers a comprehensive benefits package and a path to equity, with a collaborative, fast-paced environment.