US Regulatory Affairs Leader — Submissions & Strategy

Regulatory Jobs; United States; À distance; USD 103 000 - 138 000; Plein temps

Avantages offerts par ce poste

Equity awards

Employee Stock Purchase Plan

Comprehensive benefits package

Annual bonus plan

Résumé du poste

BeOne Medicines Ltd. seeks an experienced Regulatory Sr Associate to manage regulatory projects and submissions across clinical, non-clinical, and CMC areas. You will guide cross-functional teams on strategy and tactics, write and assemble dossiers, and ensure timely US and international submissions.

The role requires 4+ years in pharma with IND/NDAs experience, CTD/eCTD familiarity, and strong communication. A fast-paced, entrepreneurial environment and competitive benefits are offered.

Qualifications

• BA/BS in Health Science required, 4+ years in pharma.
• Experience preparing INDs and NDAs, amendments and supplements.
• CTD/eCTD knowledge; familiarity with FDA/ICH guidelines.
• Understanding GMP/GLP/GCP in life cycle of pharma products.
• Excellent oral and written communication; strong planning skills.

Responsabilités

• Plan and manage regulatory activities across clinical, non-clinical, and CMC.
• Develop strategies for earliest approvals/clearances of submissions.
• Prepare, assemble, review, and submit regulatory dossiers in US and abroad.
• Ensure compliance; support meeting requests and briefing documents.
• Manage INDs, BLAs/NDAs, supplements, annual and safety reports; participate on teams.
• Maintain regulatory knowledge and archive; work with CROs as needed.

Connaissances

Regulatory submissions planning

IND/NDAs experience

CTD/eCTD knowledge

FDA/ICH guidance knowledge

Adobe Acrobat Professional

Formation

BA/BS in Health Science

Outils

Adobe Acrobat Professional

Description du poste

BeOne Medicines Ltd. seeks an experienced Regulatory Sr Associate to manage regulatory projects and submissions across clinical, non-clinical, and CMC areas. You will guide cross-functional teams on strategy and tactics, write and assemble dossiers, and ensure timely US and international submissions.

The role requires 4+ years in pharma with IND/NDAs experience, CTD/eCTD familiarity, and strong communication. A fast-paced, entrepreneurial environment and competitive benefits are offered.