Shire Jobs

General Description :

The Executive Director, Global Regulatory Portfolio 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 senior management and project teams to plan, evaluate and recommend regulatory strategy. Externally, the individual will develop the global strategy for interaction with Health Authorities and will interface with business partners regarding development, regulatory, and registration strategies. He/she 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:

Responsibilities

Uses extensive knowledge of global regulatory environment and the ability to apply knowledge both strategically and operationally to development portfolio and projects, and marketed product regulatory issues to support corporate goals.

Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, global 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.

Oversees the preparation of global regulatory documentation and ensures timelines are met, including the review of 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.

Trains, develops, and manages an effective regulatory team via direct and 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 in collaboration with the regions, taking leadership for the regulatory contribution especially when more than one region is impacted.

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.

Required Education:

Bachelor’s degree required, advanced degree preferred.

Required Qualifications:

BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 10 years’ experience in a Regulatory capacity with a broad background or an MA/MS/MBA with 10 plus years of overall and Regulatory experience.

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 and able to identify and proactively respond to emerging regulatory trends anticipating future challenges and opportunities in strategy, able to identify scientific and/or clinical advances that impact drug development and regulations.

Integrates market needs and prioritization into strategy development. Is considered expert in global strategy development and execution with successful track record including extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record.

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 major strategic challenges (e.g., new competition, shifting market environment) and opportunities to expedite development and regulatory processes, 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.

Required 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 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 innovative 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.

Behavioral Competencies:

Integrity - Ability to demonstrate ethical behavior, understand and comply with legal and regulatory requirements, recognize and resolve unethical behavior or non-compliant situations.

Global and Strategic Thinking - Able to understand the overall picture, to think and plan holistically in order to develop a global regulatory position consistent with business needs.

Managing Relationships and Leading People – Able to develop and foster productive relationships with team members, internal and external partners, and stakeholders. Able to lead people and influence team members across the broader organization including outside of reporting line.

Driving for Results – Able to break down complex problems, assess risks/opportunities, prioritize and execute tasks in order to solve problems and achieve goals.

Managing Change and Ambiguity - Ability to learn, adapt, and develop.

Computer Skills :

Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Ability to work on a computer for extended periodd of time.

Travel:

Must be willing to travel approximately 10-20%.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.