Director, Global Regulatory Lead

Director, Global Regulatory Lead
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, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage 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 for designated projects ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as an advisor/liaison to the global project teams to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with business partners regarding global development, regulatory, and registration strategies.

This role will support programs within BeOne’s Development portfolio for Breast Cancer, a global regulatory remit.

Responsibilities

• Provides high level global strategic and operational regulatory direction and leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
• Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
• Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments.
• Supports regional team to negotiate with global regulatory authorities 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 assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
• Manages and leads an effective global regulatory project team via indirect reporting structure.
• Builds partnerships with 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.
• Mentors regulatory professionals and helps create a goal oriented culture.

Qualifications

• BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge.
• Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, 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.
• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, and interactions with Health Authorities.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills including creativity and effectiveness in identifying and addressing strategic challenges.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Communication & Interpersonal Skills

• Excellent interpersonal, oral and written communication skills.
• Skilled in conflict resolution/negotiation; fosters open communication.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Proven ability to build trust and respect within the organization.
• Ability to prioritize and handle multiple projects simultaneously.
• Interacts with BeOne employees, senior management, external business partners, and Regulatory Agencies.

Computer Skills

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
• Ability to work on a computer for extended periods of time.

Travel

• Must be willing to travel approximately 10-20%.

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: $176,000.00 – $236,000.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, and specific work location. Non-Commercial roles are eligible for the annual bonus plan, and all employees are eligible for discretionary equity awards. Our comprehensive benefits package includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants who require reasonable accommodation in the job application process may contact [email protected].

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