Senior Associate, US Regulatory Affairs

About the role

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Essential Functions Of The Job

• With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
• Ensure regulatory submissions are maintained in compliance with regulatory requirements
• Support and manage preparation of meeting requests and briefing documents
• Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
• Participate on project teams and provide expertise on regulatory matters
• Develop and maintain current regulatory knowledge and advise management of significant developments
• Prepare and maintain regulatory archive
• Work with external regulatory consultants/CRO’s as required

Qualifications

• BA / BS in Health Science, preferred, with at least 2+ years’ experience in the pharmaceutical industry
• Experience and knowledge in preparation of 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

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Pay

Salary Range: $93,600.00 - $123,600.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.

Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.