Associate Director, Global Regulatory Lead

BeiGene 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 Associate 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. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies.
   

Essential Functions of the job:

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 domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Uses 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.

• Manages the preparation and submission of global documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.

• Reviews sections of IND/CTA/CTN, BLA/NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

• 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.

• Leads the global regulatory project team.

• Manages critical issues, taking leadership for the regulatory contribution.

Core Competencies, Knowledge and Skill Requirements

• Minimum 8 years of experience in the biotechnical or pharmaceutical industry

• 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.

• Sound understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Can follow basic discussions about subjects in other scientific disciplines and assess regulatory implications of scientific and clinical data.

• Has sound regulatory knowledge, some working experience in HA interactions, regulatory procedures. Has basic understanding of other regulatory areas such as CMC, labeling, submission, etc., and how they are related to strategy development.

• Can develop global regulatory strategy by applying knowledge and experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a track record of regulatory accomplishments.

• Sound strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment).

• 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. 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 BeiGene employees and senior management.

• Interacts with external business partners and Regulatory Agencies.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.