Regulatory Strategy Lead – Oncology Submissions

BeiGene, Ltd.; Northern (KY); Hybrid; USD 110,000 - 185,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

PTO

Job summary

BeOne Medicines Ltd. seeks an experienced Regulatory Manager to plan and coordinate regulatory submissions across clinical, non-clinical, and CMC areas.

You will lead authoring and preparation of annual reports, represent Regulatory Affairs on cross-functional teams, and guide strategy and tactics for submissions in the US and abroad. The role requires strong knowledge of FDA/ICH guidance, CTD/eCTD, and experience with INDs/NDAs, with a proactive, detail-oriented, self-starting approach in a

Qualifications

• 7+ years’ related experience with a BA/BS degree is required.
• Experience with INDs (required) and NDAs (desirable), plus 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.
• 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 and superior planning abilities.
• Detail-oriented, self-starter, and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

Responsibilities

• With minimal supervision, plan and manage regulatory activities related to assigned projects spanning 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 with regulatory requirements.
• Support and manage preparation of meeting requests and briefing documents.
• Manage preparation, review, and submission of INDs, NDAs, amendments, and annual/safety reports.
• Participate on project teams and provide regulatory expertise.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Ensure compliance with archival and departmental requirements; liaise with external consultants/CROs as needed.

Skills

INDs experience

NDAs familiarity

FDA/ICH knowledge

CTD/eCTD

Regulatory strategy

Cross-functional collaboration

Attention to detail

Written communication

Education

BA/BS degree

Tools

Adobe Acrobat Pro

Job description

BeOne Medicines Ltd. seeks an experienced Regulatory Manager to plan and coordinate regulatory submissions across clinical, non-clinical, and CMC areas.

You will lead authoring and preparation of annual reports, represent Regulatory Affairs on cross-functional teams, and guide strategy and tactics for submissions in the US and abroad. The role requires strong knowledge of FDA/ICH guidance, CTD/eCTD, and experience with INDs/NDAs, with a proactive, detail-oriented, self-starting approach in a