Senior Manager, Regulatory Affairs

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

General Description

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. Ensure compliance with departmental requirements including and maintenance of regulatory archive. Work with external regulatory consultants/CRO’s as required

Qualifications

• · 7+ years’ related experience is required with a BA/BS degree
• · 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

Supervisory Responsibilities

NA

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

Salary Range

Salary Range: $139,800.00 - $184,800.00 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. 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. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Equal Opportunity Statement

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail] .