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.

The Director, Global Regulatory Lead supporting programs within BeOne's Hematology Franchise, with a focus on our BTK CDAC and BCL2 assets in development and 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 to support investigational and marketing registration packages throughout the world.
• 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

Communication & Interpersonal Skills

Computer Skills

Travel

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.

Salary Range : $171,300.00 - $231,300.00 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 accommodationsus@beonemed.com .