Director, Regulatory Affairs - US

BeOne Medicines USA, Inc.; United States; Remote; USD 176,000 - 236,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. seeks a Director of Regulatory Affairs to lead North American regulatory strategy for development programs and to secure market access in the US and Canada.

You will supervise NA regulatory activities across development, post-approval, and lifecycle management, interfacing with FDA and Health Canada. The role requires deep regulatory knowledge, leadership experience, and a track record of successful submissions and approvals in the biopharma space.

Qualifications

• 10+ years in biotechnical or pharmaceutical INDUSTRY with regulatory experience
• Bachelor's degree required; advanced degree preferred
• Lead regulatory affairs with FDA experience and exposure to small molecules and biologics
• Strong understanding of drug development and regulatory policy trends

Responsibilities

• Provide regulatory strategy and operational direction for NA.
• Liaise with FDA and Health Canada to expedite approvals and manage issues.
• Oversee preparation and submission of regulatory documentation for US/Canada.
• Ensure compliance with global regulatory strategy and timelines.
• Lead and develop a regional regulatory team; collaborate with cross-functional partners.

Skills

Regulatory strategy

FDA interactions

Leadership

Regulatory submissions

Life cycle management

Education

Bachelor's degree

Advanced degree preferred

Tools

Microsoft Office

Veeva

Regulatory publishing

PowerPoint

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

The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

Essential Functions of the job

• Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions.
• Uses extensive knowledge of US, regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
• Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader.
• Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
• Liaises and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
• Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs.
• Facilitate policy and development of standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
• Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure.
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Manages critical issues, taking leadership for the regulatory contribution.
• Responsible for assisting with the development and implementation of regulatory processes.
• Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture.

Supervisory Responsibilities

Some supervisory responsibilities for multi-level regulatory team(s).

Travel: Business travel to be 10-20% as required.

Computer Skills

Experience with Microsoft Office suite Veeva regulatory publishing PowerPoint presentation authoring and presentation.

Other Qualifications

• 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background
• Bachelor’s degree required; advanced degree preferred
• Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both small molecules and biologics
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
• Strong business acumen and ability to make sound decisions that contribute positively to the business
• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
• Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
• Skilled in conflict resolution/negotiation
• Fosters open communication
• Listens and facilitates discussion
• Strong negotiating skills and ability to think creatively and develop creative solutions
• Proven ability to build trust and respect within the organization
• Ability to prioritize and handle multiple projects simultaneously
• Interacts with external business partners and Regulatory Agencies
• Proven ability to build trust and respect within the organization. Ability to prioritize and handle multiple projects simultaneously

Salary Range

Salary Range: $176,000.00 - $236,000.00 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• 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. For more information, please visit the link to explore job opportunities in China Mainland.

China Mainland Job Posting

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

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.

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