Senior Manager, Regulatory Affairs

BeiGene, Ltd.; Northern (KY); On-site; 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 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 with a BA/BS degree is required
• 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

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. 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].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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At BeOne, how we work is just as important as the work we do.

Below are our Values that determine the decisions we make and how we do things.

Patients First Driving Excellence Bold Ingenuity Collaborative Spirit