Senior Regulatory Affairs Leader - Equity Eligible

BeOne Medicines Ltd.; United States; Remote; USD 140,000 - 185,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Stock/equity opportunity

Wellness programs

Job summary

BeOne Medicines Ltd. is seeking an experienced regulatory affairs professional to lead regulatory activities across clinical, non-clinical, and CMC programs.

The role involves planning strategies for early approvals, preparing and submitting dossiers for US and international markets, and ensuring ongoing compliance with global regulations. The ideal candidate has 7+ years of regulatory experience, strong knowledge of INDs/NDAs, CTD/eCTD, and proficiency with FDA/ICH guidance.

Qualifications

• 7+ years’ related experience with a BA/BS degree.
• Experience with INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical).
• Experience with CTD/eCTD.
• Experience with publishing documents in Adobe Acrobat Professional.
• Working knowledge of FDA and ICH regulatory guidance and regulations.
• Understanding of FDA structure and function.
• Knowledge/experience with regulatory requirements for other regions also desirable.
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
• Excellent oral and written communications skills are a must as are superior planning skills.
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

Responsibilities

• Plan and manage regulatory activities across clinical, non-clinical, and CMC.
• Assist in developing strategies for earliest possible approvals/clearance of regulatory submissions.
• Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers for US and international registrations.
• Ensure regulatory submissions are compliant; support meeting requests and briefing documents.
• Manage submission components including INDs, amendments, BLAs/NDAs, annual reports, safety reports, etc., and participate on project teams.
• Develop and maintain current regulatory knowledge; ensure compliance with department requirements and regulatory archive; liaise with CROs as needed

Job description

BeOne Medicines Ltd. is seeking an experienced regulatory affairs professional to lead regulatory activities across clinical, non-clinical, and CMC programs.

The role involves planning strategies for early approvals, preparing and submitting dossiers for US and international markets, and ensuring ongoing compliance with global regulations. The ideal candidate has 7+ years of regulatory experience, strong knowledge of INDs/NDAs, CTD/eCTD, and proficiency with FDA/ICH guidance.