Senior Manager, Regulatory Affairs - US

Regulatory Toolkit; United States; Remote; USD 140,000 - 185,000; Full time

Job summary

BeOne Medicines Ltd. in the United States is seeking an experienced Regulatory Affairs Manager to oversee planning, evaluating, and completing regulatory submissions across clinical, non-clinical, and CMC areas.

You will lead cross-functional teams, author dossiers for US and international submissions, ensure compliance with FDA guidance and CTD/eCTD, and mentor staff in a fast-paced, entrepreneurial setting.

Qualifications

• 7+ years’ related experience with a BA/BS degree.
• Experience with INDs (required) and NDAs (desirable), plus amendments and supplements.
• Experience with CTD/eCTD and regulatory publishing tools.
• Working knowledge of FDA guidance, ICH regulations, GMP/GLP/GCP.

Responsibilities

• Plan and manage regulatory activities across clinical, non-clinical and CMC.
• Develop strategies for earliest approvals/clearances of regulatory submissions.
• Prepare, write and submit regulatory dossiers for US and international registrations.
• Maintain submissions in compliance and manage briefing documents and meetings.
• Lead cross-functional teams and coordinate with CROs/consultants on regulatory matters.

Skills

Regulatory strategy

Project management

FDA regulations

CTD/eCTD

Adobe Acrobat

Communication

Leadership

GMP/GLP/GCP

Education

BA/BS degree

Tools

Adobe Acrobat Professional

Job 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.

General Description:

BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions.

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.
• Working knowledge 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

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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: $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.

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].